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Unique Considerations in Designing Decentralized Trials for Digital Therapeutics

June 7, 2022

Pam Diamond, MD

Digital therapeutics (DTx), the use of software-based interventions to prevent and treat disease, is one of the biggest areas of growth in life sciences. CB Insights reported that 2021 funding in the digital health industry grew 79% over 2020,{1} and the global DTx market is projected to hit $13.1 billion by 2026, up from $3.4 billion in 2021.{2} Many say digital therapeutics will re-write the future of healthcare.{3}

The DTx industry isn’t just aspirational. Studies show improved outcomes from DTx, either alone or in conjunction with conventional therapeutics, in a broad range of indications, including cancer, ADHD, asthma, schizophrenia, and insomnia. Some examples of products include video games to treat mental and behavioral health issues; a platform that incorporates neurological music therapy, sensors, and artificial intelligence to help patients who have suffered a stroke or other neurological disorder to rebuild motor skills; and a smartphone app that can conduct electrocardiograms anytime, anywhere.

Background

While exciting, this is still unchartered territory. Regulatory lines are often blurry between prescription DTx, non-prescription DTx, and combination digital therapeutics/traditional medication. It’s worth noting, however, that the U.S. Food and Drug Administration (FDA) has demonstrated its commitment to supporting digital health technologies through the publication of multiple guidance documents and the launch of the Digital Health Center of Excellence, which aims to connect and build partnerships to accelerate digital health advancements, in September 2020. In April 2021, too, the FDA loosened regulations surrounding approval of digital mental health tools to hasten their time to market.{4}

Even so, not all DTx manufacturers choose to seek FDA approval, but they all need to prove efficacy through clinical studies for payers to consider coverage and consumers to consider purchase. Regulatory approval is not always the end goal—or at least, not initially.

AstraZeneca, for instance, has designed a rigorous and low-patient-burden digital therapeutic to monitor metastatic breast cancer patients. The prescription DTx, which is currently being tested in clinical trials in 23 countries, was developed using insight from a review of medical literature, pulmonary and breast cancer experts, technology review, and real-world evidence gathered through conducting a deep cohort analysis of approximately 500 patients in U.S. health systems.{5} The therapeutic’s aim is to monitor patients’ symptoms and vital signs and, based on algorithms and expert rules, alert a physician as to how well the patient is doing on the treatment to maximize both safety and outcomes.

“Regulation will differentiate between a fitness app a consumer can simply download, with no regulation required, versus something that is scientifically proven to have a direct impact on someone’s health condition or outcome, which a doctor may prescribe,” said Cristina Duran, chief digital health officer for AstraZeneca, in a statement. “In a few years, I think we will see that shift to it being commonplace for your doctor to prescribe a digital therapeutic, a medication, or both.”

Indeed, it’s a complicated and quickly evolving arena in healthcare.

On top of the current regulatory limbo, DTx manufacturers face many of the same clinical trial challenges as traditional drug makers, including those tied to patient recruitment and retention, quality of data, and costs. They also must carefully consider the unique technical security concerns of an all-digital therapeutic and face strategic decisions around either provisioning smart devices or leveraging a “bring your own device” (BYOD) policy. At the same time, clinical trial models are rapidly evolving, adding further complexity for companies working to develop innovative digital therapeutics in a post-pandemic environment. Decentralized clinical trials (DCTs) are becoming a preferred model for research in biopharma and offer even greater benefits to companies conducting studies on digital therapeutics.

Wave Neuroscience, a medical device manufacturing company that specializes in designing software and physics-based personalized brain-based interventions, is moving toward more decentralized clinical trial designs. “DCTs can improve patient recruitment and retention by reducing burden and eliminating geographic barriers,” explained Dr. Erik Won, president and chief medical officer of Wave. “This also results in a more representative sampling of the population, such as patients from rural areas who often don’t have access to major institutions.”

Dr. Won continued, “DCTs can also increase the quality of data by minimizing the Hawthorne Effect—where individuals modify an aspect of their behavior in response to their awareness of being observed, also known as ‘white coat syndrome’—because patients are in their home environment.” Finally, DCTs can be more cost-effective, he added.

When Stars Align: DCTs and DTx

Fundamentally, a DTx is software rather than a pill or injectable, so there is no distribution or administration of medicines. There are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards—plus endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies whether the goal is regulatory approval or consumer and payer confidence.

In all cases, though, the unique advantage is that the DTx being studied in a trial is also the data collection device, so manufacturers often don’t need extra technologies like an electronic patient-reported outcome (ePRO) system to capture data in a clinical trial. It’s all in one, and this can result in big cost savings.

For example, Texas A&M and Wave Neurosciences are conducting a hybrid clinical trial on the safety and efficacy of magnetic EEG-guided resonance therapy to treat post-traumatic stress disorder (PTSD). This therapy uses transcranial magnetic stimulation, which has been cleared by the FDA for treatment-resistant major depressive disorder, obsessive compulsive disorder, and nicotine cessation. With this algorithm-driven therapeutic, a personalized treatment is delivered via conventional (in-person) appointments. Screening and follow-up visits, in which participant-reported data are collected, take place virtually to the extent possible.

“America is experiencing a crisis in mental health,” said Dr. Won. “Software- and physics-based personalized therapeutics are a modern, non-pharmaceutical, non-invasive option to help in this area. We are testing our therapeutic with an eye to pursuing an FDA marketing approval for the PTSD indication. We are exploring the decentralized trial model to introduce greater flexibility and speed into our research efforts.”

Best Practices for Designing DTx Trials

With the quickly growing and evolving DTx market, and the complexities associated with clinical research, here are five considerations for decentralized trial design:

  1. Know your regulatory roadmap before embarking on a trial.

Because the regulatory pathway for digital therapeutics is not as clear-cut as it is for traditional investigational drugs, it is critical to outline your regulatory roadmap before recruiting the first patient. Feasibility studies can be a good place to start, especially to help map out an expansion plan down the line. Some important considerations also include how future versions of your DTx product will be tested, benchmarked, and evolve over time.

“It is always best to seek meetings with the FDA’s device division [the Center for Devices and Radiological Health] early, and often,” said Dr. Daniel Karlin, chief medical officer at MindMed, a clinical stage biopharmaceutical company developing novel products to treat brain health disorders. Dr. Karlin is also the lead medical advisor to the makers of the first and only FDA-cleared, prescription DTx that improves sleep in adults 22 and older with nightmare disorder or nightmares related to PTSD.

Dr. Karlin continued, “It is easier for DTx providers to secure meetings with the FDA because digital therapeutics are typically less biologically complex and therefore pose less risk. Request a meeting at the start of your development efforts to agree on the claims you plan to make based on the indication for use, and to establish what related evidence will satisfy the FDA. This is fundamental. Also, seek institutional review board [IRB] clearance on anything that could conceivably be research-related before you bring an experimental device to humans for studies.”

Of course, regulatory approval—while often considered the ultimate validation for the safety and efficacy of a drug or device—isn’t the only reason for conducting clinical research, especially with DTx. Health economic outcomes and human factor research are often equally important for product adoption. Even in the digital realm, real-world function and outcomes are important to create products that lead to meaningful outcomes for patients. “All manufacturers want payers and patients to be confident in our product’s efficacy, safety, and economics,” added Dr. Won.

For instance, some DTx products that have minimal risk may not require regulatory approval but are just as valuable as those that do. Decide if regulatory approval is on your short-term or long-term roadmap and design the trial accordingly. If it is not, then there is greater flexibility in study design.

  1. Map out an immediate and long-term commercial strategy.

Given how quickly the DTx marketplace is evolving, the best that can be done may be to sketch out a preliminary commercialization strategy that has plenty of leeway to deviate from that path, if necessary. For instance, if your therapeutic will not be intended for regulatory approval, you may need to focus on a consumer strategy that focuses on everyday wellness. If you know this up front, you can design your clinical trial around endpoints that mirror your target consumer’s biggest pain points. However, if your end-goal is to develop a DTx that will be used in combination with an FDA-approved drug, then you will need to design your trial based on endpoints relevant to that drug maker’s target patient population.

  1. Carefully consider and incorporate protections against technical security breaches.

Data security and privacy are crucial for all clinical trials, but especially when studying DTx that are 100% tech-driven and, therefore, potentially vulnerable to more issues. One of the most important decisions that needs to be made up front is whether the protocol will strictly enforce a BYOD strategy (which could prevent some patients from participating) or require the sponsor to provision devices to all participants (which could be cost-prohibitive)—or some combination thereof. Each option comes with different security considerations, so decide this up front.

Regardless of device strategy, all data collected on the smartphone will need to be encrypted and then sent to a secure central platform in the cloud that follows all regulatory compliance parameters. Additionally, invest in a platform provider or tech-enabled CRO that maintains a strict security perimeter, including a “zero-trust” architecture with individual logins and audit trails for everyone who has access to the data every time they log in or out—this, on top of the digital therapeutic app’s security standards.

  1. Develop digital endpoints that are fully validated and meaningful to patients.

Traditional medicine trials measure against accepted endpoints that are validated in accordance with standards set forth by the IRB and regulatory organizations. However, DTx studies are typically measuring novel digital endpoints that are different for each DTx app and do not have a history of vetted benchmarks against which to be validated. Even so, reviewers will need to ensure that the novel endpoints aren’t bogus, and this can require some extra steps and creativity.

In many cases, endpoint validation in DTx studies requires a comparison to something similar that has been already validated or the use of previously vetted ratings scales. For example, when conducting a depression study, the DTx sponsor may first administer the Columbia-Suicide Severity Rating Scale—a suicidal ideation and behavior rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh, and New York University—to potential participants at screening. The patient’s score can be the baseline for the study, so if the DTx is efficacious, that score should drop and serve as a validated digital endpoint for symptoms of depression.

Similarly, DTx studies may leverage ePROs to administer quality-of-life questionnaires compared against prior research already accepted and validated by the IRB and FDA. Another way to validate endpoints in a decentralized DTx trial is to incorporate an initial site visit with a clinician who can compare the measurement of, say, a wearable device against an equivalent onsite, hospital-grade machine. Doing so can prove the wearable is as valid a measuring tool as another.

Finally, as important as endpoint validation is patient validation—in other words, identify the measurements or endpoints that are meaningful to patients. For example, with Fern Health’s digital musculoskeletal platform, the company shifted the focus of pain management from pain relief to functional restoration. Early on, the company found that functional pain endpoints are more important to patients in the long term than pain relief alone and made that critical adjustment.

  1. Assess the use of DTx placebos or sham apps early and often.

In a DTx clinical trial, dummy or “sham” apps are often used as a control in comparison to the actual treatment or intervention app—like a placebo pill used in a randomized control trial. There are unique considerations in using sham apps, however, including the potential for an unintentional placebo effect.

Here is the challenge: It is very difficult to make a sham app similar enough to the real one, which means patients often suspect that they were not assigned to the treatment arm. In addition, patients who do interact with the sham app can experience a placebo effect that negatively skews study results. For instance, patients in the treatment arm of a study would typically show significant symptom improvement compared to the non-treatment arm, but when using a sham app, that disparity is not as dramatic.

The FDA has not yet ruled on whether placebos or “sham” apps must be used in DTx trials, but the agency often prefers a sham control. DTx companies that opt not to use a sham control will need to work very hard to find creative ways to design an FDA-acceptable trial that won’t be criticized—even then, there is no guarantee that the FDA will accept the results.

“It is highly unusual to view sham controls as unnecessary in clinical trials,” said Dr. Karlin. “Not only do regulatory bodies prefer sham-controlled evidence in digital therapeutics studies, but also clinicians. Reluctance to use sham apps will cause companies to struggle to get both FDA clearance and physician buy-in, which is critical for commercial success with patients.”

Dr. Karlin’s team for the PTSD DTx leveraged a sham control on a wearable device that, rather than buzz when detecting a nightmare, simply recorded it. “When we assessed the reliability of our blind through a survey of our trial participants, we found that most did not know whether they were using the real therapeutic or the sham,” he noted. “This helped validate the research because it meant that we could reliably compare the active intervention with the placebo for more meaningful results. Randomization and sham control are not magic bullets, but they’re the best options we have right now.”

As the Digital World Turns…

There’s still a lot to be learned in the DTx market, but they are here to stay with growing reliance, trust, and adoption of digital health products. COVID-19 pushed researchers to lean into the decentralized model for research, and the pandemic has simultaneously fueled a growing need for DTx products—an ideal marriage of process and product. Remaining flexible and open-minded will be critical to succeed in this evolving and exciting area—as the digital world turns.

References

  1. Taylor NP. 2022. Digital Health Funding Jumps to New High. MedTech Dive. See full resource here.
  2. Market and Markets report. 2021. Global Digital Therapeutics Market Projected to Reach USD $13.1 Billion by 2026. ReportLinker. See full resource here.
  3. Taranto B. 2021. The Growing Power of Digital Healthcare. TechCrunch. See full resource here.
  4. Staff report. 2021. DTx Trends and Companies to Watch in the Growing Digital Health Industry. Insider Intelligence. See full resource here.
  5. Galbraith S. 2021. Digital Therapeutics: Augmenting Patient Outcomes. AstraZeneca. See full resource here.

Digital Therapeutics Deliver Surprising New Benefits for Cancer Patients

June 7, 2022

Digital technologies have had profound effects on how we communicate (i.e., smartphones), share information (i.e., social media), and create (i.e., 2- and 3-D printing). Now, they are having an impact in healthcare, too. The latest (and arguably most exciting) example is digital therapeutics (DTx): medical treatments to address health conditions via a combination of software and communications. DTx are in use or being tested for a growing list of diseases and conditions: Type 2 diabetes, congestive heart failure, obesity, Alzheimer’s disease, dementia, asthma, substance abuse, hypertension, anxiety, depression, and more.

Digital Health or Digital Therapeutics?

Researchers and policymakers make distinctions among digital health (the overall category of health-related interactions), prescription digital therapeutics (apps or tools that have gained regulatory approval), and software used as an adjunct to guide a healthcare provider’s treatment of a patient (software as a medical device, or SaMD, regulated in the US by the FDA Center for Devices and Radiological Health). There are overlaps from one category to another but, in nearly all cases, a rigorous evaluation in the form of a clinical trial to clearly demonstrate the impact of the digital technology is needed, even when regulatory approval is not the end goal.

“Digital solutions have a variety of intended use cases which drive their approval pathway, and they are equally valuable and important depending on the end goal,” said the head of digital health, oncology R&D at a top-10 pharmaceutical company that has digital therapeutics in development across therapeutic areas. “Whether the digital therapeutic is for consumer health assessment or in a trial or routine care setting, following the guidance around use cases and a carefully developed measurement framework is critical to ensure scientifically rigorous and responsible assessment of a patient’s health status.”

In parallel with the maturation of DTx, numerous researchers have been examining the social or patient-centered aspects of oncology care, especially now that oncology care is becoming a participant in the DTx evolution. The opportunities for improving health outcomes in oncology through DTx arise from challenges expressed by many cancer patients: surgery, radiation, chemotherapy, and/or immuno-oncology, all carried out over several years and with substantial side effects. Sleep, eating patterns, and physical activity can be affected. For many patients, simply withstanding the course of treatment is a victory, let alone what happens to their cancer.

Researchers think that digital therapeutics can help. One pre-market prescription DTx company dedicated to improving mental health in cancer patients is conducting various clinical trials on new DTx products designed to improve cancer-related distress that affects a patient’s quality of life or ability to cope with cancer diagnosis and treatment, which affects nearly half of cancer patients. According to the company, “digital therapeutics that help to treat cancer-related distress have the potential to help close the cancer treatment gap.” DTx products may incorporate cognitive behavioral stress management, which has been tailored to cancer patients and shown in numerous clinical studies to improve emotional well-being, physical health, and overall survival.

“We will continue to prioritize the study and development of digital therapeutics for real-time, continuous patient monitoring, from side effects of treatment to symptoms of disease that indicate progression. The aim is to allow patients to stay on therapy longer, have fewer side effects and adverse events, wherein this improved treatment tolerability may potentially lead to increased benefit from therapy,” added one top-10 pharmaceutical company’s head of digital health.

For at least the past decade, researchers have been documenting longer survivals, better adherence to therapy, and improved quality of life (QoL) when various forms of digitized health or therapeutic actions are taken. A lung cancer study comparing symptom monitoring using a DTx versus the standard process conducted in France in 2017 was so successful that it was prematurely halted and patients in the control group were transferred to the study group receiving the digital intervention. The median overall survival was 22.5 months in the digital intervention group versus 14.9 months in the control group.

Another app-based symptom reporting study at Memorial Sloan Kettering found a five-month extension of median overall survival among solid-tumor cancer patients, along with improvements in QoL during treatment. “One potential mechanism of action is early responsiveness to patient symptoms preventing adverse downstream consequences,” the researchers summarized.

Despite these early successes, organizations often must run clinical trials to reinforce the value of digital intervention to all stakeholders including not just regulators, doctors, and patients but also payers, who seek health economics data. DTx manufacturers are increasingly leaning into the decentralized clinical trial (DCT) model for its speed, efficiency, data quality, and patient-centric advantages.

Now a widely accepted trial model in the aftermath of the COVID-19 pandemic, DCTs use software to connect patients to trials. Travel to and from the trial site is minimized or eliminated; interaction with trial participants can be frequent (or, in cases where wearable medical devices are involved, it can be 24/7); and there are few geographic limitations, so participation can be more representative of the population.

In addition, there is a fundamental alignment between a DTx and a DCT. Since DTx is software rather than an oral or injectable formulation, there is no physical distribution or administering of medicines, just as there are often no physical sites in a DCT. There are no logistics: No shipping, storing, chain of control, cold storage, or biohazards; in addition, endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies. In the case of combination DTx/traditional studies in oncology, however, there will likely need to be some in-person site visits, so a “hybrid DCT” approach may be ideal.

Here are three key benefits of hybrid DCTs in oncology DTx development:

DCTs Boost Patient Recruitment, Retention, and Engagement

Patient retention and engagement have long been challenges in clinical research, but DCTs have had a uniquely positive impact on digital therapeutics studies. DCTs make participating in research easier and studies more accessible to participants who live far away from study centers or are unable to visit trial sites for various reasons. Without the need to perform all assessments at a clinical trial site, sponsors can successfully recruit patients from greatly expanded geographic areas. Opening studies up to more participants optimizes the patient pool and reduces the need to overenroll based on anticipated attrition or dropout rates.

Decentralization Improves Cost Efficiency

DCTs save costs, in part, by saving time. For instance, the single biggest time drain in drug clinical trials is patient recruitment, which can take about one-third or more of the duration of the entire trial and contributes to a trial’s high price tag. Similarly, recruiting a diverse patient population and keeping them engaged for DTx studies is draining. By expanding the geographic area for recruitment, DCTs speed recruitment across a more representative patient population. By removing many of the burdens associated with traditional trials, DCTs decrease dropout rates in DTx studies.

In addition to the financial benefit that comes from saving time, DCTs require less staffing and greatly reduce the need for sites and infrastructure. In fact, for many growing DTx companies, lengthy brick-and-mortar trials are unnecessary because they don’t have the same scope or needs as a randomized phase 2 or phase 3 study. The technology that DTx companies need to run a trial is materially different from the technology needed for a traditional drug trial. Further, much of the software needed for a DTx trial is already baked into the DTx app used in the study, so many of the components (such as EDC software) required for traditional clinical trials involving prescription drugs are not needed. This is not to suggest that a decentralized clinical trial is any less valid–just more innately streamlined. As a result, DTx companies can save substantially–reducing the costs by a factor of 20 or more–by picking just the technology needed rather than paying for complete functionality of an application or irrelevant bells and whistles.

This benefits the patient, too. Patients who use one app to complete all trial forms find participation much easier than using different devices or going into a site for repeat visits. Again, a better patient experience decreases study dropout rates and results in even greater savings and improved trial data.

Data Quality Improves with DCTs

DCTs enable DTx companies to collect real-world data directly from patients where they are most comfortable, minimizing the “white coat” effect, which has a quantifiable impact on data quality in the form of increased blood pressure in response to a clinician visit. Having a wider (more diverse) trial population means that the data collected are more reflective of real-world conditions; moreover, the potential for more precise data collection from patient interactions can translate into more granular data analysis.
“Digital therapeutics are prescribed by a doctor often alongside a medicine, so it’s very reasonable to expect that we’ll see more DTx and drug combination regimens emerge in oncology in coming years,” concluded one top-10 pharmaceutical company’s digital health leader. “Combining innovative new treatments with evidence-based digital health solutions is one way we can think more holistically about cancer patient care to improve health outcomes.”

 

Invest in Technology, Profit in Better Health Outcomes

June 7, 2022

Improving preventative care and chronic disease management has helped slow the process of aging. In the United States, the 65 and older population has grown by over a third in the past decade, and the number of adults aged 85 and older is expected to nearly triple by 2060. Yet, living longer comes with risk. Genetic mutations are generally managed by the body’s ability to perform necessary repairs. However, with increasing age, the number of mutations also increases, which can give rise to cancer. Indeed, people aged 67 and older represent half of cancer patients and cancer is the second leading cause of death for people aged 85 and older. We owe it to ourselves to do something about this.

While the primary purpose of research is to learn, clinical research also seeks to advance treatments if possible. Many oncology patients, particularly those with aggressive disease, know that access to the most advanced medicines may entail being a part of a clinical trial. In comparison to other disease groups, cancer trials have the fewest age caps for enrollment. This is partly because, unlike chronological age or the number of years alive, physiological age (or how old one is due to genetics and lifestyle) is a better indicator of a patient’s ability to tolerate harsh treatment regimens and related toxicities. Older age is generally associated with reduced organ function and poorer performance status scores, which are risky for institutions ill-equipped to manage therapy-induced complications. Furthermore, sponsors would prefer to minimize instances of negative effects from their drugs; in response, many cancer clinical trials have an upper age limit of 70 to 80. Disappointingly, the median age of cancer participants enrolled in trials is an average of 6.49 years younger than that of patients with the same cancers not enrolled in trials. In essence, cancer patients who are granted entry to clinical trials are typically younger, fitter, and likelier to tolerate research regimens, while older, higher-risk patients are left without immediate access to potentially life-prolonging therapy. The very people who are most likely to require treatment with innovative therapies will not reap the benefits of a rigorous testing process.

Fortunately, these same patients are widely adopting technology: More than half of US adults age 65 and older own smartphones and 75% use the internet. Cancer patients are more likely to complete web-based questionnaires than paper-based forms. Oncology researchers often consider in-person follow-up essential to ensure safety and wellness in study participants. But this begs the question of whether the risk of missing an in-person observation outweighs the risk of transporting the infirm. Unless patients are so sick as to require hospitalization, are they not better off in the comfort of their homes, avoiding communicable infections for at least part of a trial’s duration?

One study shows that cancer patients who are offered the telehealth option improved communication with their providers, had 38% fewer hospital admissions and 31% fewer readmissions, and improved quality of life. This is significant because older cancer patients prefer quality of life over length of life. For cancer patients, untreated symptoms like gastrointestinal upset and pain can turn serious rapidly. Digital in-home symptom tracking tools for patients receiving chemotherapy offer pattern-recognition, severity detection, and real-time symptom management which reduce symptom burden by 43%, decrease the number of emergency room visits, and mitigate costs.

Advances in technology allow us to play 4-D video games, turn down our home’s heat while traveling in another state, and print objects from a personal-use device, yet we go about clinical research in an archaic fashion. Investment in our health is surely as important as investment in fun-to-haves, and yet trial participants remain too familiar with paper surveys, long clinic visits, and delayed responses to adverse events. If there is ever a time for clinical research to get up to speed with technology-driven industries, it’s now. And elderly cancer patients must be the focal point of this endeavor.

There are already pioneers committed to this mission. The Collaborations in Health, Aging, Research, and Technology (CHART) at the University of Illinois at Urbana-Champaign has constructed a research-focused “smart home” to learn how the elderly may benefit from using smart appliances, assistive robotics, and home sensors. Tools like these may seem like a luxury to some but could be essential for those who would otherwise rely on caregivers to meet basic health needs and achieve a sense of normalcy. If access to these tools improves someone’s ability to participate in a clinical trial–because they can now do just about anything a younger, healthier person can do, just differently–industry sponsors should pay attention. One cannot discount the cost of owning smart devices and tools. Insurance coverage and reimbursement programs could make a big difference in affordability. Traditional (less new) technology often carries the benefit of reduced or no cost for use. Examples include phone applications, wearable devices, and voice-operated mobile assistants.

It is important to note that some barriers to maximizing technology use in the elderly do exist. For instance, difficulty reading from small screens, manipulating voice-activated software, and understanding evolving terminology are a few. But these challenges are not insurmountable. Understanding how the elderly utilize technology is a step in the right direction. By engaging multidisciplinary research teams in rich discussions with patients and their caregivers, the potential for developing truly smart, customizable technology is vast. It may not be long before augmented reality glasses can be used for easily viewing and completing drug diaries as well as participating in virtual health visits. An automated call to a clinician when an in-dwelling catheter detects low levels of circulating red blood cells may be just around the corner. A bit of foresight, some creativity, and an incorporation of technology can allow investigators to spend more energy focusing on collecting and generating meaningful remote follow-up data that eventually improves treatment access and outcomes for elderly patients.

At present, we can only hope that our parents, grandparents, and even our future selves, if faced with cancer, will thrive in old age–not alone, but with the companionship of our aging loved ones. We can make this a reality by applying technology and thinking “outside of the (clinic) box” to bring our cancer clinical research to our elderly cancer patients.

Decentralized Trials Begin to Show Their Value in New Ways

Mar 25, 2022

The more experience clinical research professionals gain in conducting full or hybrid (onsite/offsite) decentralized clinical trials (DCTs), the more advantages beyond simple economics and convenience for patients they are realizing from the tactic, contributors to the next issue of ACRP’s Clinical Researcher journal suggest.

For example, in her forthcoming column on “Unique Considerations in Designing Decentralized Trials for Digital Therapeutics,” Pam Diamond, MD, cofounder and chief medical officer of Curavit Clinical Research, quotes an expert from the medical device arena as saying that DCTs can increase the quality of data by minimizing the Hawthorne Effect—where individuals modify an aspect of their behavior in response to their awareness of being observed. This phenomenon, also known as “white coat syndrome” in healthcare situations, is thought to be less of a factor when patients are in their home environment.

Diamond goes on to write that, “Fundamentally, a digital therapeutic (DTx) is software rather than a pill or injectable, so there is no distribution or administration of medicines. There are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards—plus endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies, whether the manufacturer’s goal is gaining regulatory approval or consumer and payer confidence.”

Meanwhile, in a column on “The Ecosystem of Decentralized Clinical Trials: It Takes a Village to Modernize Care,” MaryAnne Rizk, PhD, chief strategy officer for Medable, notes that, when “companies coordinate their efforts to design and execute DCTs, sponsors, investigators, and patients see the benefits. A connected ecosystem of DCT collaborators can streamline operations and data collection and resolve interoperability challenges. With a coordinated approach, the industry will accelerate this new model to make better medicines faster, safer, and more effective for every biology around the world.”

Rizk adds that, to navigate the new waters of DCT delivery, leading organizations are coming together to create a network of “best-of-breed, trial-enablement providers” that “includes contract research organizations, traditional and nontraditional investigator sites—including new retail pharmacy sites—and leading data and technology services providers” responsible for a range of trial support technologies and processes.

Still, Kristin Mauri, solutions services director for Remarque Systems, in her column on “DCTs: Key Considerations for Small-to-Midsized Biotech and Biopharma Companies,” looks at how the DCT trend may seem daunting for companies that feel that “the risks of treading this new territory—an area with complex data management demands and no clear regulatory guidance—outweigh the potential rewards.” However, Mauri adds that if some companies feel that DCTs are outside their comfort zone and budgets, that is not necessarily true.

As just one consideration, Mauri notes how, “untethered from sites, DCTs can recruit from anywhere, which often leads to faster enrollment and fewer screening failures. Further, that same geographic freedom also means fewer sites, thus fewer review boards, potentially lower regulatory costs, and greater flexibility around protocol amendments.”

Further, in his column on “A Hybrid Approach to Decentralized Clinical Trials,” Clincierge Cofounder and CEO Scott Gray writes that, “Moving forward, we must continue to assess the value provided by DCTs in ensuring patient experience and safety remain of the utmost priority. We should continue to build upon what has been learned since the onset of the pandemic. It is up to clinical trial stakeholders to determine the best approach for balancing the needs of patients and their caregivers against the goal of contract research organizations and pharmaceutical study sponsors. Whether that means a decentralized, traditional, or hybrid course, prioritizing clinical trial patients’ health and best interests ultimately encourages higher enrollment, increased retention, and more robust data collection results.”

The June 2022 issue of Clinical Researcher, with these columns and other content touching on DCTs and data analysis for trials, in addition to three peer-reviewed articles, will go online on or around June 21 on the ACRP website.

DCTs are also the focus of a recent whitepaper on Decentralized Clinical Trials: Perspectives for Clinical Research Professionals developed by expert members of the ACRP Fellows and sessions presented at April’s ACRP 2022 conference (such as by thought leaders from Clario and Northwell Health), the recorded contents of which will soon be available in the Online Conference Library.

Digital Therapeutics Companies Lean into Decentralized Clinical Trials

Mar 25, 2022
Digital Therapeutics Companies Lean into Decentralized Clinical Trials

While digital therapeutics (DTx) companies are extremely optimistic about the promise of software-based interventions to prevent and treat diseases, they are still navigating unchartered territories around the best practices for clinical research, including patient recruitment and retention, quality of data, high costs, and uncertainty around regulatory guidelines.

At the same time, clinical trial models are rapidly evolving, adding further complexities. But one thing DTx companies do agree on is that the decentralized clinical trial (DCT) model is key to overcoming their biggest hurdles and improving the entire clinical research process.

A Patient-Centric Approach

Patient retention and engagement have long been challenges in clinical research, but DCTs have had a uniquely positive impact on DTx studies. DCTs make trials more accessible to participants who live far away from study centers. Opening studies up to more participants, optimizes the patient pool and reduces the need to over-enroll based on anticipated attrition or drop-out to improve cost efficiency.

Dr. Mike Aratow, Co-founder and Chief Medical Officer of Ellipsis Health, a DTx company that developed the first voice vital sign to quantify and manage depression and anxiety, explains, “A decentralized model not only aids patient recruitment because it removes many of the burdens associated with traditional trials, but it also makes it easier to reach underrepresented groups and those from a wider geographic landscape, providing real-world evidence and ecological validity. In traditional research, a significant amount of the medical data can’t be reproduced due to issues around patient retention and patient participation.”

Feel Therapeutics develops digital biomarkers and therapeutics for mental health using a proprietary wrist-worn wearable device. It monitors various physiological signals to extract insights on patients’ psychological and physical health. According to Feel CEO George Eleftheriou, “DCTs help optimize patient recruitment and improve engagement and retention. Wearable and digital technologies remotely measure endpoints while engaging participants in an unprecedented way and which naturally aligns with digital therapeutics that are intended to integrate into patients’ everyday lives. It is indicative that participants in our digital programs use our app for over 55 minutes per week.”

Reduced Costs

In 2020, Insider Intelligence predicted the global DTx market would hit $9 billion by 2025, but a year later sharply upped that forecast to $56 billion.1 Despite this market growth, the DTx industry is still in its infancy with most companies considered startups with modest resources. Cost efficiency is central to their success—and another reason why a DCT model complements the DTx business strategy.

DCTs save costs, in part, by saving time. For instance, the single biggest time drain in clinical trials is patient recruitment, which can take up to 30% to 40% of the duration of the entire trial process. By streamlining this process using digital tools and expanding the geographic area for recruitment, DCTs have faster recruitment, and require less staffing and infrastructure. DCTs allow researchers to customize DTx trials based on exact needs, patients, and commercialization strategy.

Additionally, the technology needed to run a DTx trial is materially different from the technology for traditional trials. Much of the software needed for a DTx trial is already baked into the DTx app being studied, so many of the robust components required for traditional clinical trials involving prescription drugs are not needed. DTx companies can save substantially—reducing the costs by a factor of 20 or more—by cherry-picking just the technology needed to run the DCT.

New data backs up the value of DCTs. According to a 2022 study by the Tufts Center for the Study of Drug Development, which compared published benchmarks on trial cycle times and costs with data from more than 150 DCTs conducted by trial software firm Medable, decentralized Phase 2 studies are completed one to three months faster than traditional trials and the time savings yield a net benefit that is up to five times greater than the upfront investment required. Decentralized Phase 3 trials with similar time savings yielded a net benefit that is up to 14 times greater the upfront investment.2

Improved Data Quality

Decentralized trials enable DTx companies to collect real-world data direct from patients where they are most comfortable, which has a quantifiable impact on data quality.

Dr. Erik Won, President and Chief Medical Officer of Wave Neuroscience, a DTx company that specializes in treating brain disorders, explained, “DCTs increase the quality of data by minimizing the Hawthorne Effect—a reactivity in which individuals modify an aspect of their behavior in response to their awareness of being observed, also known as ‘white coat syndrome’—because patients are in their home environment. With a decentralized trial, we get the best of both worlds. We can use other mechanisms to ensure that patients are following protocols while ensuring compliance. For instance, we record EEGs using wearables and ask patients to complete simple online surveys.”

DCTs also enable researchers to capture data and endpoints directly within the digital therapeutic itself for seamless data capture and less potential for “lost” information.

“DCTs enable us to collect passive, continuous, and objective data from users 24/7/365 and move from episodic patient-reported outcomes to continuous data collection,” added Feel’s Eleftheriou. “This rich data provides real-world evidence and allows us to explore novel biomarkers or digital endpoints in neuroscience and other chronic conditions with a high prevalence of mental health comorbidities, such as multiple sclerosis, certain cancers, and cardiac problems.”

Regulatory Approval

DTx companies operate in a nebulous regulatory environment, even as the Food and Drug Administration (FDA) works to clarify requirements. For example, the FDA has demonstrated its commitment to supporting digital health technologies recently through the publication of multiple relevant guidance documents as well as the founding of the Digital Health Center of Excellence (DHCoE) in the fall of 2020.

Yet, the regulatory landscape is complex, evolving quickly and differently in each country. Regulatory approval is not always required to go to market, disincentivizing studies. Many DTx manufacturers are left to make decisions on their own on whether they choose to seek regulatory approval, depending on their commercialization strategy and often take a bifurcated approach—seeking FDA approval for one variation of their product and not for another.

Wave Neurosciences follows FDA guidelines for conventional trials while making adaptations in non-FDA studies to maintain regulatory compliance. These “bridge” studies are often smaller, faster, less expensive and designed to gather enough validated data to determine if taking the next step to an FDA-approval study makes sense. In these cases, especially, a decentralized model makes it much easier and faster to stand up a “bridge” trial for DTx companies looking to determine what the next best steps should be for their product and commercialization strategy.

The Perfect Pairing

Fundamentally, DTx products are software, so there are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards plus endpoints can be captured directly within the DTx application, making DTx studies ideally suited for the digitally enabled decentralized model.

Even so, much is still to be learned in the emerging DTx market. While COVID may have forced researchers to lean into DCTs and the pandemic continues fueling a growing need for digital therapeutics, this perfect pairing will only benefit the industry and society a whole.

References:

1. Insider Intelligence, “DTx Trends and Companies to Watch in the Growing Digital Health Industry,” by Staff (July 29, 2021). See full resource here.

2. FierceBiotech, “Not Just for a Pandemic: DCTs Pay Off Financially, a Study Shows,” by Gareth Macdonald (January 12, 2022). See full resource here.

Despite rapid DCT evolution, there’s still room for progress: Curavit

Mar 9, 2022

A leader from the VCRO shares how far the industry has come with decentralized adoption, where opportunities for improvement exist, and what lies ahead.

While the pandemic knocked many clinical trial operations for a loop, the decentralized clinical trial (DCT) format has fueled a comeback since COVID-19’s arrival. Dave Hanaman (co-founder, president, and chief commercial officer of Curavit) spoke with Outsourcing-Pharma about progress made, lessons learned, and the road ahead.

OSP: How have decentralized trials evolved in the past two years?

DH: The biggest evolution has been the adoption of decentralized clinical trials (DCTs) by sponsors that would not have considered them without the catalyst of the pandemic. Before the pandemic, DCTs accounted for only 2-4% of trials and were projected to increase about 10% over the next 10 years. The pandemic and lockdowns forced the industry to get creative.

While there was a feeling early on that the use of DCTs might decline when the pandemic was over, the benefits of the model and the continued threats of new COVID variants proved otherwise. Now the DCT market’s estimated value is a staggering $1.63b USD by 2027, an annual growth rate of 14.8%, according to Precision Reports.

Much of this growth over the past six to 12 months is a result of the exploding digital therapeutics (DTx) market and their adoption of DCTs. According to Report Linker, the global DTx market is projected to reach $13.1b USD by 2026, up from $3.4b USD in 2021. These DTx companies are bringing novel software-based therapies and diagnostics into the market and their business and delivery models line up almost perfectly with DCTs because of the way these trials are designed from digital-first principles.

Gaining real-world results from a decentralized trial

Feb 8, 2022

When Lark Health decided to embark on its most recent decentralized trial with Curavit, a virtual CRO, its leaders saw the potential for a host of benefits.

According to OraLee Branch, the trial’s principal investigator and Lark’s director of clinical studies and research, a decentralized clinical trial (DCT) would be more patient-centric and convenient. It could boost efficiency, would likely be faster, and could help with recruiting a diverse population.

Lark joins an increasing amount of small to midsize companies now transitioning to DCTs, which provide solutions for a number of common logistical headaches.

It was also a natural fit for the midsize digital therapeutic company, which uses a cognitive behavioral therapy approach to create mobile apps aimed at managing and preventing chronic diseases, such as diabetes and hypertension. The apps’ features also include personalized coaching, and use artificial intelligence to help support lifestyle changes, such as weight loss, quitting smoking, or managing stress.

“I came to Lark from an academic background. I was a principal investigator and a full professor at various leading medical universities. So, I have a lot of experience in clinical trials and in managing decentralized, multi-site institutional trials,” Branch says.

For their upcoming study, which will test the use of a chronic disease prevention and management program, Lark wanted to enlist the help of other experts.

“We wanted a CRO who has had this kind of expertise, so that we can focus on what Lark does best, which is have great programs and great experiences for the user,” says Branch.

As an added bonus, they hope that having an outside CRO coordinating and managing data will bolster data integrity.

“We want this to be a high data integrity representation and the easiest way to do it is to have that external collection,” she says.

Here, Branch discusses how Lark plans to gain from using a DCT and how it is overcoming challenges associated with this approach.

PharmaVoice: What advantages do you hope decentralization will bring in terms of recruitment?

OraLee Branch: In conventional trials, which are typically brick and mortar or in-person trials, the people who end up participating are a select group. They are what you’d call a biased collection of participants. These are people who are willing and able to travel to the facility where the trial is conducted. People who join trials are sometimes more health conscious than the average person, or more likely to be from an urban versus a rural area. Participants also tend to be less diverse, or from different socioeconomic backgrounds than the general public. We want to remove that bias from the trial. That allows us to study people who are more likely to be the future users of Lark, so that the results that we’re obtaining are applicable to the general population. We want to make sure that we’re reaching the people who we know will be the users of our program.

Are there other benefits of a decentralized trial?

We are also hoping to connect a lot of fragmented information. We want to link laboratory results with clinical findings, and with the user’s every day well-being measures. That is why we really have our eyes on this decentralized clinical trial.

Oncology: Surprising Therapeutic Area Ripe for Decentralized Research

Feb 7, 2022
Surprising Therapeutic Area Ripe for Decentralized Research
Given the complexity of cancer, some researchers are skeptical about the use of a decentralized clinical trial (DCT) model for oncology research. However, DCTs offer tremendous benefit, particularly in decreasing patient dropout rates and increasing patient engagement, two critical factors for oncology.

Oncology represents the largest research area globally, with 6.5% annual growth from 2000 to 2020 compared to 3.6% for nononcology drugs in development. At the same time, oncology trials face unique challenges including patient enrollment and retention problems, complex trial designs across more sites, larger data sets, longer durations, and more protocol deviations (to name only a few). In fact, the three phases of oncology trials last almost 12 years, on average, compared to 8 years for nononcology trials. And oncology trials generate a much higher volume of data: 3.1 million data points per protocol in phase 2 oncology compared with 1.9 million in nononcology.

It’s no surprise that, as of June 2021, only 5% of the 4,576 trials utilizing DCT strategies are oncology studies. Various explanations for this lag may include the type of investigational product, the need for invasive tests and scans, and the uncertainty surrounding the effect of remote assessments on data quality. However, a well-designed DCT that considers regulatory and operational concerns can not only overcome these issues but also improve research performance, data quality, and speed.

Wrong Assumption: Cancer Trial Patients Prefer In-Person Visits

Many cancer patients would prefer to stay home. For instance, patients diagnosed with acute myeloid leukemia—a cancer of the blood and bone marrow that progresses rapidly—juggle many physical and psychological side effects from the time they receive initial treatment through their post-hospitalization course. Prolonged symptom management, often involving nausea and fatigue, makes outpatient visits particularly challenging. Follow-up oncologist appointments are already time-consuming and may include blood transfusions, intravenous medication delivery, and comorbidity management. Tacking on additional research assessments before patients can go home may be more than they can bear.

DCT technologies enable remote monitoring so ailing cancer patients can remain in the comfort of their homes and reduce the burden of in-person visits, in turn, attracting more trial participants. Continuous remote monitoring provides the added benefit of better real-world data.

Pete, a middle-aged survivor of acute lymphoblastic leukemia, endured an arduous, three-year chemotherapy course. Three months into his treatment, he entered a clinical trial using blinatumomab, which was taken in parallel with his chemotherapy. Within just one month, his leukemia disappeared completely, but due to risk of recurrence, Pete underwent three more cycles of trial drug. Today, he sees considerable value in a DCT approach during the maintenance and monitoring phases, which will last for the next three years.

“I do televisits with my oncologist now, which is much easier,” said Pete in an interview for this article. “You can’t replace in-person visits in the early stages of a trial, but virtual technologies can ease the burden long-term.”

Digital Therapeutics Sector Projected to Grow Exponentially

Jan 24, 2022
Digital Therapeutics Sector Projected to Grow Exponentially

As the digital therapeutics/software as a medical device sector continues its significant growth, clinical trials for the products are projected to expand logarithmically.

The space is seeing a big transformation from merely following patient symptoms to serving as interventions in a growing number of areas, according to Mark Opler, chief resource officer for directing research and development at WCG MedAvante-Prophase.

“This used to be, I would say, almost a fringe category of potential treatments. It’s moved considerably from symptom tracking to intervention,” Opler told CenterWatch Weekly. “There is an ever-widening array of conditions and symptoms that digital therapeutics are intended to treat. Mood disorders, particularly depression, anxiety, those have been traditionally thought of as the core target categories for digital therapeutics, but as time goes by, we’re seeing applications to psychosis, to trauma and to other diseases, including attention deficit and related conditions.”

The FDA has already approved a number of digital therapeutics products. These include Akili Interactive’s EndeavorRx, an ADHD videogame treatment for children, NightWare’s self-titled product that uses an AppleWatch and iPhone to disrupt nightmares without disturbing sleep and a trio of Pear Therapeutics apps for chronic insomnia, opioid use disorder and substance use disorder.

Digital therapeutics can also be developed to serve as coaching tools to help improve certain behaviors. While some are intended to serve as standalone products, others are being developed for use in combination with drugs or other medical devices. The sector’s growth is predicted to grow to $12.1 billion by 2026.

Because patients are using a piece of software, not simply taking a drug, determining what will be used as the placebo can be a taller order. Some companies come up with “inactive,” nontherapeutic software to serve as the placebo, while others develop games or use treatment as usual for patients in the placebo control group.

But according to Opler, it may be more fruitful to concede that this method of blinding “may be on some level challenging, if not impossible” and go another route: using an evaluator that has as few ties as possible to the trial beyond assessing patient symptoms, an avenue for blinding that’s gained greater traction in digital therapeutics trials.

“What’s transpired instead when you want to evaluate efficacy in an objective way in a digital therapeutics study is to have a fully independent and blinded evaluator, someone who is blinded as much as possible to the treatment and the study design, and whose only contact with the patient is evaluating their symptoms,” Opler said. “It’s tough to find the sugar pill equivalent in a digital therapeutics trial. Blinding the evaluator, keeping them independent from other aspects of conduct of the study, is another route to ensuring that the evidence we gather is rigorous and will be acceptable to the larger community.”

Endpoints are another big issue for digital therapeutics trials, according to Dave Hanaman, president and chief commercial officer of Curavit, a virtual CRO…

View Full Article

Curavit Earns HIPAA Seal of Compliance

Jan 10, 2022
HIPPa Seal of Compliance

BOSTONJanuary 5, 2022 Curavit Clinical Research announced today that it has taken all necessary steps to prove its good faith effort to achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA). Through the use of Compliancy Group’s proprietary HIPAA solution, The Guard™, Curavit can track its compliance program and has earned its Seal of Compliance™.

The Seal of Compliance is issued to organizations that have implemented an effective HIPAA compliance program using The Guard. HIPAA is made up of a set of regulatory standards governing the security, privacy, and integrity of sensitive healthcare data called protected health information (PHI). PHI is any individually identifiable healthcare-related information. If vendors who service healthcare clients come into contact with PHI in any way, those vendors must be HIPAA compliant.

Curavit has completed Compliancy Group’s Implementation Program, adhering to the necessary regulatory standards outlined in the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, Omnibus Rule, and HITECH.  Compliancy Group has verified Curavit’s good faith effort to achieve HIPAA compliance through The Guard. 

“HIPAA compliance is imperative for clinical research, increasingly so as the clinical trial model becomes more decentralized,” said Joel Morse, co-founder and CEO of Curavit. “As a virtual contract research organization that designs clinical trials from digital first principles, we take patient privacy very seriously, and have built our alwaysaudit-ready platform on validated technologies that support our HIPPA compliant processes.

According to a statement by Compliancy Group, “Clients and patients are becoming more aware of HIPAA compliance requirements and how the regulation protects their personal information. Forward-thinking providers like Curavit choose the Seal of Compliance to differentiate their services.”

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs) from digital first principles. Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality and reducing patient burden. Curavit brings together the world’s leading researchers, enrolls previously underrepresented and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. For more information, visit www.curavitclinicalresearch.com.

Media Contact: Lisa Barbadora   (610) 420-3413   lbarbadora@barbadoraink.com

PM360 Presents the 2021 Innovators

Dec 13, 2021
PM360 Presents the 2021 Innovators

Innovation. Transformation. Change. Adapt. These words and all their synonyms were repeated ad nauseum during these past two years as people, companies, organizations, and industries were forced to make drastic changes in the face of a global pandemic. As Rajiv Sodhi, COO, Microsoft India, said, “Innovation is no longer an option, but a necessity.” That was in relation to a Microsoft-IDC study in which 77% of businesses in India said that innovation is now a “must” for them to respond quickly to market challenges and opportunities.

Of course, this isn’t an issue isolated to just one country or one industry. According to BCG’s April 2021 report, “Overcoming the Innovation Readiness Gap,”  75% of the 1,500 global executives surveyed across all industries said that innovation is top-three priority at their company—a 10 percentage point increase from 2020, which is the largest year-over-year increase in the 15 years of BCG’s Most Innovative Companies survey. Furthermore, more than 60% of companies plan to boost investment in innovation, with one-third of them planning to do so significantly.

If these companies stick to their word, we may be entering a new age of innovation. That may be a sight to behold because in our industry alone, the innovations over the past two years have been significant. Yes, that includes COVID-19 vaccines developed in record time, but it’s more than that. Healthcare delivery, clinical trials, commercialization efforts, organization management, and much more were all reimagined to work better during a pandemic and even well into the future as we embrace our next normal.

For the past decade, our annual Innovations Issue has served as your guide to all things new and next in the industry to better prepare you for the future. As innovation only grows more crucial, so does this guide. From hundreds of submissions, we picked the most gamechanging innovations you need to know about in the following categories:

  • Companies (any organization developing new ways to push the industry forward)
  • Divisions (new sectors formed to address a particular problem facing the industry)
  • Startups (companies less than five years old pioneering new avenues in healthcare)
  • Products (software, apps, programs, and anything else designed to improve how those working in the industry do their jobs)
  • Services (compelling offerings that help the industry tackle new challenges)
  • Strategies (never-before-tried approaches that are changing how the industry operates)

These selections are meant to aide in your own innovation journey with potential partners, worthwhile offerings, and inspiring ideas that can help you stay ahead of the game in a world that has now made innovation one of its top priorities.

Advantages of Digital Decentralized Trials with Curavit’s Dave Hanaman | Interview

Dec 8, 2021
Advantages of Digital Decentralized Trials with Curavit’s Dave Hanaman | Interview

President & Chief Commercial Officer | Curavit

Nov 15, 2021
Dave Hanaman

NEXT FRONTIER: The next frontier for clinical trials is in-silica research, also – confusingly – called virtual trials. In this future of research, “subjects” are computer models, data is real world data (RWD), and the experiments are conducted through computation – not human observation and measurement. There are already some good examples of this. The Economist recently reported on the one from the UK, but it will be a very long time before this is a significant disrupted to clinical research.

Curavit Clinical Research announced the appointments

Oct 20, 2021
Jay Collier

Curavit Clinical Research announced the appointments of Jay Collier, as Chief Operating Officer, and Candice Del Rio, as Director of Clinical Operations.

Insights into Definining Decentralized Clinical Trials

Oct 20, 2021
Dave Hanaman

Decentralized Clinical Trials (DCTs) have taken the main stage in the clinical trials industry, which was significantly facilitated during the pandemic. However, similar to the initiation of risk-based monitoring (RBM), the concept of DCTs is at an infancy stage, and many enterprises are competing to make their mark in the field. This prompted the formation of the Decentralized Trials & Research Alliance (DTRA) to help better define and advance DCTs. In this article, Dave Hanaman, Co-founder of Curavit, will discuss his perspectives on DCTs.

Moe Alsumidaie: What is a Virtual CRO (VCRO)?

Dave Hanaman: Co-founder Joel Morse and I conceived the company from our experience at C3i, where we spent 20 years at the intersection of digital technologies and clinical research. We saw this space evolving for years and wanted to disrupt research by positively applying technology in new ways. So we launched Curavit officially in November 2019 and became the first virtual CRO—a contract research organization dedicated exclusively to designing and executing decentralized clinical trials.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

DH: Yes, and the technology is catching up to the vision. In 2007, Veeva introduced cloud-based CRM to an industry desperate for lower-cost technology models because so many major brand-name blockbuster drugs were coming off patent. Veeva’s well-touted success is an example of the right solution at the right time. Decentralized trials are similarly destined, supported by developments in IoT, wearables, and big data. People have been working to make DCT a reality for years, but the technology is finally maturing and readily available while the industry is calling for a greater focus on patients and access to trials for all. So once again, we have a case of the right solution at the right time.

MA: Are there concerns around data privacy and what precautions is Curavit taking to protect it, especially now where the U.S. and many Western nations are under attack by foreign hackers. What can be done to address those concerns using a DCT model for research?

DH: From banking to life sciences, every industry is extremely concerned about protecting data. As in most things, there are tradeoffs. Decentralized trials that do not involve sites can be an advantage in limiting data risk. DCTs can be much more secure in many ways because you can centralize data in very safe, modern cloud systems. That is what Curavit is doing.

Curavit’s platform has been purpose-built for decentralized trials with proven, industry-leading software. HIPAA compliance and validation are built into the individual tools as well as the overall platform. No corners were cut in terms of applying modern cyber defenses.

MA: Part of Curavit’s vision is to make research more accessible across all the demographics. How are you expanding clinical trials to those demographics through DCTs?

DH: First, DCT technologies and processes are fundamentally more suited to reaching previously underserved or underrepresented patient populations. It’s easier to expose more people to the opportunity to participate in research across social media, digital communities, and websites supporting specific diseases or conditions.

Second, and more specifically, DCTs leverage community-based outreach. For example, we partner with Clinispan out of North Carolina whose purpose is to recruit underserved populations. Par 80 in Boston partners with community health centers serving minority populations. These efforts reach out to minority populations to include those who distrust or have not been previously exposed to research.

Third, we have had ongoing discussions with a global pharmaceutical company interested in Native American populations that embody two distinct underserved groups: indigenous and rural populations.

MA: Where do you see DCTs going in the next ten years?

DH: Optimistically, in 10 years, we won’t think of DCTs as unusual because the technologies and processes will be commonplace. DCTs won’t be any more novel than computerized businesses are today.

Most data capture will be in the cloud a decade from now, and DCTs will enable a more burdenless patient research experience. To clarify, that doesn’t mean face-to-face interactions with physicians will go away. Even in complex therapeutic areas like oncology, there’s plenty of opportunities to use digital technologies to gather new data and reduce patient burden. We won’t think of DCTs as a distinct subset. In 2031, DCTs will have disrupted clinical research in profound ways that are better for all patients, better for all sponsors, and ultimately better for public health.

Decentralized Clinical Trials: What Therapeutic Areas are Ripe for All-Virtual?

Oct 20, 2021
Pam Diamond | Curavit Clinical Research

Before the pandemic, a December 2019 Industry Standard Research survey found that 38% of pharmaceutical sponsors and contract research organizations (CROs) expected virtual trials to be a major component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. One year later when attendees at McKinsey’s Clinical Operations Roundtable were asked the same questions, the responses were 100% and 89%, respectively.

Today, most are asking what trials and what aspects of trials can be effectively decentralized and to what degree. Fully virtual or decentralized clinical trials (DCTs) typically handle all enrollment processes and assessments in a patient’s home, enabled by end-to-end digital tools and involve the self-administration of medicines. This model is gradually migrating from smaller, early-phase and post-approval studies toward larger pivotal trials, such as Otsuka and Click Therapeutics’ landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing symptoms in adults diagnosed with major depressive disorder (announced in Feb 2021).

In the near term, sponsors, investigators, and CROs expect fully virtual trials to remain limited to a narrow set of use cases, such as a well-characterized drug with few adverse events in a mild indication, with end points suited to remote measurement. Long-term, however, fully virtual trials will be more widespread—especially in certain therapeutic areas such as rare disease, mental health, central nervous system, neurodegenerative and others that require patient populations that can’t physically travel or don’t live near a site.

Ultimately, the therapeutic area alone shouldn’t determine a trial design. Rather, each trial should be designed for-purpose and centered on patients. The target patient population, treatment, and indication will primarily determine whether a trial is fully virtual, hybrid or a traditional site-based trial. Even so, there are defining patient population characteristics in many therapeutic areas that can make some studies more likely candidates for all-virtual research.

Here are five therapeutic areas that are particularly apt for an all-virtual research approach, and that can serve as an entry point for hesitant sponsors interested in exploring this growing DCT model.

Diabetes—More than one in 10 Americans have diabetes and one in three or 88 million adults are prediabetic. Given the disease’s prevalence and its widespread geographic reach including many rural areas, diabetes is ripe for fully virtual research. Blood glucose values can be monitored continuously with wearable devices attached to the patient’s skin and automatically uploaded to a central platform in the cloud for easy access by trial investigators, sponsors, and the patients themselves.

In addition, the propensity of patients with Type two diabetes to be elderly or struggle with obesity can make it difficult for patients to travel to trial sites. These patients often have vascular problems which also can also hinder mobility. Further, diabetes is rampant in certain demographics such as Native Americans who are twice as likely to have diabetes as whites and often live in remote rural areas far away from the nearest clinician. Virtual trials bring lifesaving treatment to these patients and further the development of treatments that reflect the unique needs of a more representative population.

Cardiovascular—With wearable devices, including Apple watches, that monitor increasingly more sophisticated and wider range of cardiovascular endpoints remotely, research focused on cardiovascular diseases are apt for a fully virtual trial design. These devices accurately monitor and measure cardiac events and catch issues, such as atrial fibrillation (a common type of sustained cardiac arrhythmia) and ventricular tachycardia (abnormally fast heart rate) to alert the patient and remote physician in real time. Even some clothing items, such as bras, have sewn-in heart monitors! There are other devices that can be worn continuously for months at a time to capture more sophisticated measurements and automatically send data into the cloud. The same is true when it comes to managing blood pressure.

Like diabetes, cardiac patients are in all corners of the world and often many hours from central research sites and—due to their condition—may have mobility challenges and concerns. Virtual trials extend access to the millions living with heart disease and high blood pressure. Further, the data gained from continuous and multiple-symptom monitoring of cardiac patients is dramatically more useful in comparison to the less-reliable, one-hour, single-symptom testing completed at a site once a month or every few months. Heart arrhythmia often occurs only intermittently so it may not be picked up at the occasional site visit. Today’s wearable devices monitor blood pressure, heart rate and rhythm, and oxygen saturation levels as well as activity level (steps taken) so researchers can superimpose different measurements depending on what endpoint is being studied or combine multiple measurements for more meaningful information.

Central nervous system (CNS) diseases—Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s disease, and other CNS diseases may dramatically impact patients’ mobility as well as hamper caregivers’ ability to bring affected loved ones to frequent clinician visits. All-virtual trials open these patients up to potential opportunities they might not otherwise ever have for a treatment.

Like cardiac wearable devices, there are an increasing number of new technologies that allow researchers to measure novel endpoints of patients in the comfort of their own homes and in more realistic life settings outside of a doctor’s office. Devices can continuously measure number of hand tremors per minute, for example, so a novel endpoint could be the reduction of hand tremors which was not as easily studied in traditional trials.

An electroencephalogram (EEG) is a widely used non-invasive method for monitoring the brain but has historically been a large and bulky technology, restricted to the monitoring of subjects in a lab or clinic while they are stationary. Today, we can use a wearable EEG, which overcomes these limitations and allows the long-term, non-invasive recording of brain signals at home.

Neuromuscular trials—Like patients with CNS disorders, patients struggling with neuromuscular diseases, including Duchene Muscular Dystrophy may have severe mobility challenges that make it difficult to make regular clinician visits. Fortunately, there are advanced activity monitors that do not interfere with movement on these patients such as ankle bracelets that can record various measurements continuously to, say, show how much activity a person takes part in over a period. Red Nucleus Clinical’s iTakeControl platform is a clinically approved solution that enables HIPAA-compliant video assessments of patients, live video research visits and audio recording to provide richer audio/visual data that is also auditable for compliance purposes.

Decentralized Clinical Trials Poised to Expand Their Reach

Oct 19, 2021
Dave Hanaman

An understanding of human nature suggests that in a post-COVID-19 era for clinical trials, the pendulum may temporarily swing away from the increased adoption of decentralized clinical trials (DCTs) and hybrid approaches that we’ve been witnessing and revert to something more closely resembling the traditional, in-person trial conduct practitioners and patients had been used to before 2020. However, Dave Hanaman, chief commercial officer for Curavait Clinical Research, sees “steep continued growth” in the years to come for new technologies and approaches that he believes can significantly advance the quality and reach of clinical trials.

“DCTs present a new opportunity to meet patients wherever they are,” says Hanaman. The approach they offer represents “an effective way to bring the trial to the patients,” he adds.

Acknowledging some industry “growing pains” as hybrid trials and DCTs have begun to take hold, Hanaman warns that some hybrid approaches are “the worst of both worlds,” with too heavy a physical footprint and overuse of technology.

However, Hanaman sees “strong levels of adoption” for hybrid trials in the next five to 10 years. “Much of the resistance has dropped,” he explains. “I think their use will be taken for granted” in the years to come, he says.

Hanaman is excited, too, about how hybrid trials and DCTs can expand the reach of clinical trials. In addition to traditionally underserved patient populations like African Americans and Hispanics, Hanaman notes the new technology and approach could improve trial access for native American and rural white populations. “Native American populations are often very far away from physical research sites,” he notes.

Further, internet coverage, long an obstacle to increased use of telehealth and DCTs, has improved in many of even the most geographically remote parts of the United States, Hanaman says.

DCTs and hybrid trials represent “a tremendous opportunity for patients and science,” he says. “I see so much more enthusiasm for [such approaches] to be included in trial design, and [they] will help us better reach the patients we’ve been missing.”

Meet The Disruptors: Dave Hanaman Of Curavit Clinical Research On The Three Things You Need To Shake Up Your Industry

Oct 11, 2021
Dave Hanaman

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Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit more. Can you tell us a bit about your “backstory”? What led you to this particular career path?

At my previous company, my co-founder, Joel Morse, and I spent 20 years at the intersection of clinical research and digital health technology, working with the world’s leading pharmaceutical companies. We became very interested in the ways that these technologies and processes could benefit patients, researchers, and healthcare organizations. I am very happy to be working with him and several other former colleagues now at Curavit, which launched in 2019.

Can you tell our readers what it is about the work you’re doing that’s disruptive?

At Curavit, we are designing and executing decentralized, or “virtual,” clinical trials, which are the application of digital technologies, wearable devices, internet-of-things, innovative trial design, and supportive regulation to increase the speed and fidelity of clinical research, while simultaneously attracting previously undeserved patient populations.

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

While not exactly a “funny” story, I have one that was completely unexpected. We announced Curavit at a major clinical research conference in January of 2020, when the industry was breathlessly predicting that 10% of all trials would be “virtual” in ten years. No one foresaw the impact of the pandemic and the unprecedented forced adoption of decentralized trials within months. We found ourselves suddenly accelerating toward our goals with massive tailwinds, but also buffeted by lots of noise and turbulence from the hype. We again learned the lesson that “the first casualty of battle is the plan,” and that you have to stay committed to the outcome while adapting to the things you can’t control.

We all need a little help along the journey. Who have been some of your mentors? Can you share a story about how they made an impact?

I learned so much from the men and women I served with in the Navy. From my Marine drill instructor, to the commanding officers I worked for, to my squadron mates and colleagues, they continue to inspire and motivate me every day. And of course my family; I have always enjoyed the full support of my wife and sons through the good, bad, and most of all uncertain times associated with being an entrepreneur.

In today’s parlance, being disruptive is usually a positive adjective. But is disrupting always good? When do we say the converse, that a system or structure has ‘withstood the test of time’? Can you articulate to our readers when disrupting an industry is positive, and when disrupting an industry is ‘not so positive’? Can you share some examples of what you mean?

I believe that “disruption” is a neutral word and that in practice it usually results in both positive and negative outcomes, depending on one’s perspective. For decentralized clinical trials (DCT), a good example might be the impact on sites. Are DCT’s “site-less” trials? Sometimes. Does that mean that some sites are negatively impacted by DCTs? Yes. But the flip-side of that may be reducing patient burden and increasing diverse enrollment, and those are positives. Furthermore, as with most disruption, it won’t be that simple. In this example, I believe some sites will prosper by embracing DCT technologies and processes, benefiting themselves as well as patients.

Can you share 3 of the best words of advice you’ve gotten along your journey? Please give a story or example for each.

One of our sales people once said, “If you’re explaining, you’re losing!” This means your value to your customers has to be clear and compelling.

An early advisor to my first company said, “Sometimes, you gotta tell ’em the baby is ugly.” In other words, don’t be afraid to see and speak the truth.

And recently, one of our current investors (and an advisor to our company) reminded me that my ultimate job is to detach and put myself in our customers’ shoes. Our success depends on our ability to meet and exceed customer needs and expectations over the long term.

We are sure you aren’t done. How are you going to shake things up next?

Curavit is my “next” right now. We are in our formative stage and are building out our team. We have an opportunity to do a lot of great work for the next few years and help shape the future of clinical research. That’s plenty for now, so no clear plans for a “next thing” just yet!

Do you have a book, podcast, or talk that’s had a deep impact on your thinking? Can you share a story with us? Can you explain why it was so resonant with you?

I usually read fiction or philosophy every night, even if only for a few minutes. In the gym or the car, I’ll listen to podcasts and audiobooks on a broad (and non-business-specific) array of topics often touching on history, exploration, geopolitics, and leadership. Right now I’m listening to the audio book “A Hunter Gatherer’s Guide to the 21st Century,” and just finished a 9/11 retrospective podcast series on Michael Morell’s  podcast. Apropos of this interview, a keynote presentation that still resonates with me was one I heard years ago by Dr. Clayton Christensen on his seminal book, “The Innovator’s Dilemma.” That talk still informs my thinking around our strategy at Curavit today.

Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?

I love quotes, and keep a list of my favorites. In this context, I’ll pick Theodore Roosevelt’s famous words found in “Man in the Arena.”

“It is not the critic who counts, not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man in the arena, whose face is marred by dust and sweat and blood, who strives valiantly…who knows the great enthusiasms, the great devotions, who spends himself in a worthy cause, who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who have never known neither victory nor defeat.” — Teddy Roosevelt

The most rewarding aspect of being an entrepreneur for me is commitment in the face of adversity and uncertainty which TR captures so well in that speech.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. 🙂

It would simply be to encourage people who are considering a different path to take the risk of engaging in a new venture. Of course we should plan and prepare, but eventually one simply has to make a leap of faith.

How can our readers follow you online?

You can find me and the rest of the Curavit team and follow our progress at https://www.linkedin.com/company/curavit/ and https://www.linkedin.com/in/davehanaman/.

This was very inspiring. Thank you so much for joining us!

 

Curavit joins decentralized trials group, predicts demand will keep growing

Oct 5, 2021
Curavit joins decentralized trials group, predicts demand will keep growing

Curavit has joined the Decentralized Trials & Research Alliance, an industry-backed non-profit organization focused on the promotion of remote studies.

Membership of the group will see Curavit take part in the development of the fast growing the decentralized clinical trials market according to co-founder, president and chief commercial officer, Dave Hanaman.

“DTRA provides a broader platform for Curavit to discuss the innovations and research improvements that we are driving for our clients. Curavit will also have the benefit of collaborating with other innovators to solve new or emerging challenges in a way that is meaningful for the entire industry.”

Demand for decentralized trials has increased significantly in recent years – particularly since the pandemic – Hanaman told Clinical insider and predicted demand would continue.

“Curavit sees demand for DCTs daily in the form of customer feedback. Clients are developing long-term plans to leverage decentralized components in most of their trials. COVID-19 changed the industry’s approach, impacting everything from long-range planning to execution and it doesn’t seem like we are going back to traditional methods.”

He added, “Today, most trial designs have at least on decentralized component included and every large pharmaceutical company Curavit has spoken to over the last year has established a DCT group or team – often referenced as innovation team, trial optimization group, digital team or other similar nomenclature denoting DCTs.”

Curavit was established in 2020 in a bid to tap this growing section of the market. Last month the CRO expanded its sales team in a bid to broaden its service.

Hanaman said, “Curavit is a new company and establishing its sales force from scratch, so we need team members to support the demand. Prior, just Curavit founders have been managing client inquiries and working with clients to ensure long-term satisfaction and responsiveness.

“With our growth, that is not sustainable, as the Curavit leadership also need to devote time to helping to develop unique therapeutic-area-specific solutions for our clients.”

Image: Stock Photo Secrets

 

Curavit Clinical Research: team appoints

Oct 7, 2021

Decentralized Trials & Research Alliance Grows, Partnerships in Site Conduct, Trial Diversity, More

Oct 7, 2021

Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trials & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals. Curavit Clinical Research has also announced the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020.

Chapel Hill startup targets seed funding after working to diversify Novavax Covid-19 vaccine trial

May 16, 2020
Chapel Hill startup targets seed funding after working to diversify Novavax Covid-19 vaccine trial

A Chapel Hill startup that helped bring diversity to Novavax’s (Nasdaq: NVAX) clinical trials for its Covid-19 vaccine is in the process of raising $250,000 in funding to help it continue to grow.

CliniSpan Health is actively raising seed funding to grow its team of eight to 20 by 2022, said Dezbee McDaniel, the company’s co-founder and head of business development who earned his undergraduate degree from UNC-Chapel Hill.

“We are looking to grow rapidly,” McDaniel said.

The company was started with the goal to bring more diversity to clinical trials, and in January the Novavax trial was the first CliniSpan began recruiting for, McDaniel said. About 17 percent of the Black participants at the Durham clinical trial site and 20 percent at the Chapel Hill site were referred to Novavax by CliniSpan, McDaniel said.

The lack of diversity in clinical trials has been an ongoing problem for years.

In 2020, the U.S. Food and Drug Administration approved 53 novel drugs that had clinical trials with a total of 32,000 patients. Of those patients, 75 percent were white, 8 percent were Black, 6 percent were Asian and 11 percent were Hispanic.

“We are heavily focused on African Americans right now,” McDaniel said. “We want to expand to groups who are Latinx, Native American, rural, women – a lot of other diverse groups who also need access to clinical trials.”

For now, the company is focusing on one population at a time, McDaniel said, because each group has a different history with the medical system and different preferences for how they want to be communicated with.

“With African Americans, the past mistreatment by the health care system is what we have to overcome and that’s something we haven’t directly affected, so it’s difficult to have that conversation sometimes,” McDaniel said.

Having people who reflect those groups do the outreach and recruitment helps make people more comfortable in participating, he said.

The transition to more decentralized trials also helps, McDaniel said.

“If people don’t have to show up physically and they can do it from home, then access for us becomes that much easier of a goal to achieve,” he said.

In addition to the Novavax trial, CliniSpan has partnered with Curavit, a fully virtual clinical trial organization, which perfectly complements CliniSpan’s infrastructure, McDaniel said.

CliniSpan has also signed a licensing agreement for its software with Capstone Health Alliance, a group purchasing organization for hospitals, he said.

“That’s something we’re trying to grow outside of our recruitment services,” McDaniel said. “We’re trying to help other diversity recruitment arms have technological infrastructure to carry out their processes more effectively.”

At the same time, CliniSpan will be helping to recruit for studies that its hospital network participates in, McDaniel said.

CliniSpan, which is led by founder and CEO Dr. David Lipsitz who did his residency at UNC-Chapel Hill, is currently working with five businesses in total and is generating revenue, though McDaniel did not disclose how much.

17 Virtual Clinical Trial Providers to Partner up With

Apr 7, 2020
17 Virtual Clinical Trial Providers to Partner up With

Virtual clinical trial providers are your must-partners for any decentralized trial or contingency plan. In March 2020 the FDA encouraged sponsors to assess alternative methods for keeping their trials on track within the existing limitations under Covid-19 quarantine. Remote/virtual trials are no longer just a convenient way to shorten timelines and reduce costs but a rescue solution to ongoing clinical trials. From recruiting participants to designing their virtual experience, remote trial providers and technology can save your data and your budget.

Beech Tree Labs Selects Curavit Clinical Research to Push Toward 100% Virtual Clinical Trials

Sept 20, 2021

Beech Tree Labs has developed a novel drug development platform known as resonant molecular signaling (RMS), that aims to address a wide range of illnesses by restoring normal cellular communications and correcting various imbalances triggering problems. The company opted to go virtual for their next Phase 2, FDA-authorized clinical trial to evaluate the effect of Beech Tree’s BT-TML therapy targeting COVID-19 patients. Although many companies have moved to at least some provisional virtual or hybrid approach during the pandemic, Beech Tree Labs took another step toward a permanent move to virtual trials by partnering with Curavit Clinical Research for a fully decentralized trial. The Park City, Utah-based venture has an ambitious plan to disrupt the operation of clinical trials, accelerating timelines and reducing cost while maintaining if not improving quality with improved, patient-centric care.

Move to Decentralized or Virtual Trials more than ‘Flipping a Switch’

Recently, TrialSite writer Joseph Constance assessed the emerging virtual clinical trials landscape particularly in the midst of the COVID-19 pandemic. In an earlier piece, Constance suggested the move to decent…

Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials

Feb 20, 2020
A new clinical trials company, Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials.

A new clinical trials company, Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials.

Launched by industry veterans Joel Morse and Dave Hanaman, the new entity will focus on virtual trials.

Curavit Clinical Research co-founder and CEO Joel Morse said: “Curavit is the result of our desire to solve growing challenges to the important work of drug discovery.

“By combining experience, technology, and solid execution, we will bring cutting-edge research to previously untapped and underserved patient populations.”

Curavit Clinical Research is a next-generation clinical trial enterprise that provides decentralised clinical trial execution. It takes a clean-sheet approach to clinical trials, from the design phase to execution.

Optimised on a new virtual model, the company supports patients’ participation from wherever they live.

Curavit Clinical Research chief commercial officer and co-founder Dave Hanaman added: “We are fortunate to have worked with some of the most respected companies and visionary people in the life sciences industry, and are honored by the support we are receiving from them for this effort.”

Global clinical trials market stands at $70bn and continues to grow, while the success rate of trials continues to see a decline. This is often due to lack of enrollment by patients and participation from doctors.

Press Releases

Ripple Enterprise software to be deployed as part of the digital transformation in clinical trials spearheaded by Curavit.

Apr 12, 2022

ANN ARBOR, MI- April 12, 2022 – Ripple Science, a digital clinical trial software company, today announced a partnership with Curavit Clinical Research (Curavit) to deploy Ripple Recruit, the company’s newly expanded enterprise software platform, to support several digital therapeutic decentralized clinical trials. Ripple is a natural fit for Curavit’s digital-first disruptive approach to engaging patients, conducting research, and accelerating time to market of new discoveries, especially in the exploding field of digital therapeutics.

“We are hyper-focused on the unique needs of DTx manufacturers, with nearly half of our rapidly growing customer base running studies on novel digital therapeutics,” said Joel Morse, CEO of Curavit, the industry’s first virtual CRO. “Ripple Recruit offers scalable, patient-centric functionality that aligns with our decentralized clinical trial service offering for emerging DTx companies.”

Ripple Enterprise is the world’s only direct-to-patient software platform designed to support decentralized, virtual, and hybrid clinical trials. Designed and audited to 21 CFR Part 11, HIPAA, GDPR and SOC2 standards, Ripple Enterprise enables the entire clinical trial industry to adopt digital clinical trial workflows driving down costs and expanding access to a more diverse pool of patients.

“We’re excited to partner with Curavit which is on the cutting edge of the digital transformation in clinical trials,” said Peter Falzon, CEO of Ripple Science. “This partnership is our largest contract to date and validates our strategic decision to invest in Ripple Enterprise as a response to customer demand for DCT enabling software at enterprise scale.”

About Curavit:
Curavit Clinical Research is a full-service, virtual contract research organization (VCRO), focused on designing and executing digital-first decentralized clinical trials (DCTs). Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, bringing trials to patients in the cloud. Curavit’s digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies more effective across diverse populations. For more information, visit www.curavitclinicalresearch.com.

About Ripple Science:
Ripple Science, a clinical trial technology company, is leading the digital transformation in clinical trials with a direct-to-patient software platform that was built by researchers for researchers. By improving the user experience, increasing regulatory compliance, and further connecting the ecosystem through digital innovation and technology, Ripple delivers real-time transparency, game-changing efficiencies, and more secure workflows & data sharing, concerning all aspects of patient engagement from first contact to last patient visit, whether virtual or in-person.

Ripple Science was named a Top 50 Company to Watch in 2021 by Michigan Celebrates Small Businesses and recognized in 2022 by Purpose Jobs and Cronicle Tech News as one of the fastest growing health tech startup companies in Ann Arbor.

Media Contacts:

Curavit:
Lisa Barbadora
Barbadora INK
lbarbadora@barbadoraink.com / 610-420-3413

Ripple Science:
Anna Falzon

Curavit Named Runner up in BioUtah’s 2022 Entrepreneur & Investor Life Sciences Summit Pitch Competition

Apr 7, 2022
Bio Utah

SALT LAKE CITY, April 6, 2022 — Curavit Clinical Research, the first virtual contract research organization (VCRO), announced that it was recently named runner up in the 2022 Wilson Sonsini Entrepreneur & Investor Life Sciences Summit (E&I Summit) pitch competition, sponsored by Morgan Stanley. Curavit received the award for its innovative business model and ‘digital first’ approach to democratizing clinical research.

 

Now in its 7th year, the E&I Summit, presented by BioUtah, BioHive and the PIVOT Center, attracted a record setting 300+ registrants, along with an impressive line-up of distinguished speakers, national and local investors, and numerous Utah life sciences startups.

 

“We are so happy to be recognized in this capacity by our industry peers and to have had the opportunity to share what we are doing at Curavit,” said Dave Hanaman, Co-founder, President and Chief Commercial Officer of Curavit. “It was an honor to be able to share the stage with so many inspiring companies. Our satisfaction of being recognized by the judges was only overshadowed by the exciting ability to engage with so many innovative entrepreneurs and investors in the dynamic Utah ecosystem.”

 

The conference featured notable keynote speakers, including Jake Manoukian, Head of Investment Strategy for JP Morgan, who shared  insights on market trends and life sciences investment, and Stanford University professor Matt Vassar, who provided a thought-provoking address on “Telling Your Story.”

 

Out of a total of 21 life sciences companies, Curavit advanced to the popular Pitch Track session through a competitive selection process and went on to win second place after Eliksa Therapeutics.

 

For being named runner-up in the competition, Curavit was refunded its $1,000 registration fee, which the company donated to BioHive, an organization launched last year to brand, build and bring together the life sciences and healthcare innovation industry in Utah. The funds will be used to support local underrepresented communities, aligned with industry partners to promote K-12 STEM education, workforce development and awareness.

 

“We are thrilled Curavit sees the value in what we’re doing at BioHive to tell the story of our industry and unite all of the stakeholders for life sciences and healthcare innovation in Utah,” said Katelin Roberts, Executive Director at BioHive. “Their organization works at the nexus of patients, research and industry. Similarly, BioHive seeks to be the hub for our community, and their donation will go toward building our state into a premier life sciences and healthcare innovation ecosystem.”

 

About Curavit

Curavit Clinical Research is a Virtual Contract Resource Organization (VCRO) that designs and executes Decentralized Clinical Trials (DCT) from digital first principles. Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, eliminating the need for physical infrastructure and travel while increasing data quality. Curavit brings together the world’s leading researchers, enrolls previously underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. The company’s cloud-based, central virtual site is always audit ready.  For more, visit www.curavitclinicalresearch.com

 

About BioUtah 

BioUtah is an independent 501(c)(6) trade association serving Utah’s life sciences industry. Its member companies reflect a broad spectrum of the industry with strengths in medical device manufacturing and services, research and testing, biotechnology, biopharmaceuticals, advanced diagnostics, and healthIT, amongst others; and are a key driver of Utah’s economy and life-saving treatments and cures for patients. BioHive is a chartered organization of BioUtah. Its mission is to brand, build and bring together Utah’s life sciences and healthcare innovation community. For more, visit https://bioutah.org/.

 

Media Contacts:

Jamie Dabao Brown, +1 (626) 488-0732, jamie@barbadoraink.com
Lisa Barbadora, +1 (610) 420-3413, lbarbadora@barbadoraink.com

Home is where the trial is

Feb 7, 2022
Facing pandemic disruptions, smaller biotechs are turning to DCTs

When Curavit Clinical Research launched in December 2019, the startup was looking to blaze a new trail in the clinical trial space. Quite simply, they added a “V” before the traditional “CRO,” and positioned themselves as the “first virtual contract research organization (VCRO).”

The timing could not have been more apt — or more of a challenge. The pandemic had supercharged the move toward decentralized clinical trials (DCTs), including virtual trials, and furthered already-strong regulatory tailwinds, Dave Hanaman, Curavit’s president and chief commercial officer, says. But it also created logistical challenges and upended the company’s planned roll-out strategy.

“We fully expected that the decentralized market, while small, was going to grow at a steady pace and a lot of that would come from Big Pharma,” Hanaman says.

But trials at large companies had suddenly come to a screeching halt.

 

“Big Pharma was suddenly working from home and if you weren’t doing COVID trials, but you were in clinical research, then you were sitting at home, and you were planning things for post-COVID,” Hanaman says.

Curavit pivoted quickly, focusing even more of its attention on small and midsize companies.

“Big Pharma has the luxury to be patient and that’s appropriate. Small, midsized biotech start-ups don’t,” he says. “They’ve got venture capital, they’ve got a binary equation on success. They’re either going to be successful or they’re not.”

Many early adopters of DCTs have historically been bigger companies, in large part because they have the resources to make the transition. But it’s actually smaller and midsize biotechs that stand to benefit disproportionately from decentralization, Hanaman says.

For these companies, DCTs have provided a lifeline to keep research moving.

An outsized benefit

For smaller pharma companies, DCTs can mitigate a number of challenges — from recruitment struggles to global deployment challenges. Decentralization can also help expedite trials, allowing them to adapt quickly in response to data.

Drugs and diagnostics at small to midsize companies typically target a focused, distinct audience, and often focus on rare diseases, Hanaman says.

“Decentralized trials allow them to recruit from all over the country or potentially all over the world,” Hanaman says.

Decentralized technology can also help facilitate global, multi-site trials, says Alison Holland, executive general manager, Digital and Decentralized Solutions for Medable, a software provider for decentralized trials.

“Very few companies, including the small to midsize, are working in just one jurisdiction,” Holland says. “They’re looking for broader exposure, broader registrations.”

According to Holland, decentralized trial providers can help to plan for site-specific needs, accommodating for local data collection, privacy, and regulatory requirements, which can vary by country.

DCT technologies and devices can also speed trials, allowing for more data collection in a shorter period of time, with greater efficiency and reach, Hanaman says. Researchers can then interpret this data more quickly and accurately, which can enhance patient safety, and encourage participation and participant satisfaction. For example, if a red flag is detected on a daily measure of blood pressure, heart rate, temperature or weight, the subject can be brought in for evaluation quickly.

DCTs also make trial participation more appealing because they require less hassle and travel to research sites. Easing the process helps to encourage those who might otherwise be reluctant to participate. This is particularly true for people who are in poor health, such as oncology patients.

“If home is a relaxing, safe environment for them, they might appreciate the option to be there,” Holland says.

Understanding the challenges

There are also some inherent challenges for small to midsize biotechs that chose to go the decentralized route. First, DCTs require an up-front investment, not only in terms of dollars, but of time, focus and energy, Hanaman explains. Making the leap ultimately enables these organizations to run more efficient trials going forward — but they have to get over that initial hurdle first.

Second, deviating from traditional research practices can bring risk and scrutiny.

“If everybody adopted DCT technologies and processes then everybody would start to benefit. But when one company does it, they expose themselves, correctly or incorrectly, to be challenged on their results,” Hanaman says.

For others, the main challenge is overcoming paralysis. Many companies are interested in DCTs, but simply don’t know where to start.

“It’s such an overwhelming thing,” Holland says, explaining that companies often don’t know how to adapt technology to their individual study.

For all of these reasons, many smaller organizations choose to dip a toe into the water rather than jump in all at once.

“A vast growing middle section of trials are hybrid, and that’s really where companies can and should be,” Hanaman says. “You don’t have to be all in on one or another. One can say, ‘What are the technologies that work for us? How do we design our trial from these digital first principles, and then add in traditional components in a way that is better for patients, better for research, better for outcomes?’ And that often is in this hybridized space.”

Strategies for successful implementation

In order for decentralization to work, it has to be implemented correctly. Some companies try to design a trial in a traditional way and then shoehorn in technology, Hanaman says. Instead of being more convenient for participants, the end result is a clunkier trial that increases the burden because participants still need to go to the site, but they also need to learn the technology.

Instead, companies should take a more comprehensive planning approach.

“I would encourage everyone to not to get overwhelmed by the breadth of what a DCT could be and to think about their protocol,” Holland says. “What’s the scientific question that their protocol is trying to answer?”

In particular, she advises that companies ask how they can answer that question in a more digital fashion, that allows for choices for the site and the patient.

Both Hanaman and Holland suggest consulting with DCT support providers as early as possible in the trial design process. This can help determine how technology can best be used to achieve trial aims. Ultimately, successful DCT adoption requires a focus on one core goal, Holland says.

“DCTs aren’t about no bricks and mortar, or no sites — it’s about amplifying the relationship between the site and the patient,” she says. “If we approach it from the perspective of ‘How do we engage patients with their clinicians and caregivers more?’ then it really opens up a huge opportunity for us to transform how we deliver healthcare and how we collect data.”

PM360 Presents the 2021 Innovators

Dec 13, 2021
PM360 Presents the 2021 Innovators

Innovation. Transformation. Change. Adapt. These words and all their synonyms were repeated ad nauseum during these past two years as people, companies, organizations, and industries were forced to make drastic changes in the face of a global pandemic. As Rajiv Sodhi, COO, Microsoft India, said, “Innovation is no longer an option, but a necessity.” That was in relation to a Microsoft-IDC study in which 77% of businesses in India said that innovation is now a “must” for them to respond quickly to market challenges and opportunities.

Of course, this isn’t an issue isolated to just one country or one industry. According to BCG’s April 2021 report, “Overcoming the Innovation Readiness Gap,”  75% of the 1,500 global executives surveyed across all industries said that innovation is top-three priority at their company—a 10 percentage point increase from 2020, which is the largest year-over-year increase in the 15 years of BCG’s Most Innovative Companies survey. Furthermore, more than 60% of companies plan to boost investment in innovation, with one-third of them planning to do so significantly.

If these companies stick to their word, we may be entering a new age of innovation. That may be a sight to behold because in our industry alone, the innovations over the past two years have been significant. Yes, that includes COVID-19 vaccines developed in record time, but it’s more than that. Healthcare delivery, clinical trials, commercialization efforts, organization management, and much more were all reimagined to work better during a pandemic and even well into the future as we embrace our next normal.

For the past decade, our annual Innovations Issue has served as your guide to all things new and next in the industry to better prepare you for the future. As innovation only grows more crucial, so does this guide. From hundreds of submissions, we picked the most gamechanging innovations you need to know about in the following categories:

  • Companies (any organization developing new ways to push the industry forward)
  • Divisions (new sectors formed to address a particular problem facing the industry)
  • Startups (companies less than five years old pioneering new avenues in healthcare)
  • Products (software, apps, programs, and anything else designed to improve how those working in the industry do their jobs)
  • Services (compelling offerings that help the industry tackle new challenges)
  • Strategies (never-before-tried approaches that are changing how the industry operates)

These selections are meant to aide in your own innovation journey with potential partners, worthwhile offerings, and inspiring ideas that can help you stay ahead of the game in a world that has now made innovation one of its top priorities.

Curavit Expands Leadership and Sales Teams to Drive Continued Growth of Decentralized Clinical Trials Across Life Sciences Industry

Sept 29, 2021
Curavit Expands Leadership and Sales Teams to Drive Continued Growth of Decentralized Clinical Trials Across Life Sciences Industry

BOSTON— Sept.29, 2021 — Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of industry veterans, Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020.

Curavit continues to disrupt clinical research by enabling digitally native DCTs that expand trial access to previously underserved patients while improving patient participation, data quality, and research speed.

Jay Collier brings more than 20 years of operational experience serving global clients in life sciences and clinical research. In his role as COO, he will manage all aspects of service delivery for Curavit’s clients.  Prior to joining Curavit, Collier served in various leadership positions, most recently senior vice president of U.S. operations at C3i Solutions, a global leader in healthcare technology services. C3i was also founded by Curavit’s co-founders, Joel Morse and Dave Hannaman, who sold the company to a Fortune Global 500 company in 2018. Before C3i, Collier served in various director-level roles at Nextel.

“Having worked with Joel and Dave for nearly 20 years at their previous company, I’m excited to join Curavit to help build another successful venture that will streamline the clinical trial process with advanced technology, and essentially improve global health and save lives,” said Collier. “This is a huge opportunity to make a meaningful difference in clinical research for years to come.”

Candice Del Rio, Curavit’s new director of clinical operations, has more than 12 years of clinical research experience in academic , clinical, and industry settings. Prior to joining Curavit, she worked at Massachusetts General Hospital as a clinical research nurse and an oncology/hematology nurse for over a decade. She will bring her in-depth experience in the areas of clinical trial development, patient recruitment and retention, and process improvement to manage projects and ensure customer success.

In addition, Curavit welcomes Chris O’Shaughnessy, as vice president of business development, who also comes from C3i Solutions; Bill Dreyer, as director of business development, previously manager of business development for EPL Archives, Inc.; and Troy Hall, as director of business development, who last served as a cardiovascular institutional specialist at Johnson & Johnson.

“It’s an exciting time at Curavit as we grow along with the rapid evolution and adoption of decentralized clinical research,” said Joel Morse, co-founder and CEO of Curavit. “We are taking it to the next level and our new team members will bring their collective expertise to help drive innovation and customer satisfaction, while delivering our scalable and purpose built clinical trial platform to our clients.”

In other news today, Curavit announces its membership into the Decentralized Trials and Research Alliance (DTRA). The DTRA includes 100 organizational members who represent the diverse ecosystem needed for the adoption of decentralized research methods, including sponsors, regulatory authorities, patient advocacy groups, contract resource organizations, technology companies, investigator sites, and other key stakeholders.

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs). Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. Current clients include Frequency Therapeutics, Beech Tree Laboratories, Brown University, and Boston Medical Center. For more information, visit www.curavitclinicalresearch.com.

Media Contacts:

Jamie Dabao Brown, +1 (626) 488-0732, jamie@barbadoraink.com

Lisa Barbadora, +1 (610) 420-3413, lbarbadora@barbadoraink.com

First All-Virtual CRO, Curavit, Joins the Decentralized Trials & Research Alliance

Sept 29, 2021
First All-Virtual CRO, Curavit, Joins the Decentralized Trials & Research Alliance

BOSTON— Sept. 29, 2021 — Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trial & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals.

Established in 2020, the DTRA enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

“We are extremely gratified to welcome Curavit to the ‘Decentralized Trials & Research Alliance,’ said Amir Kalali, MD, founder of several collaborative life science communities, and co-Chair of DTRA. “By advancing decentralized research we can make the clinical trial process more patient-focused, increase trial efficiency and encourage use of technologies. We are excited by Curavit’s commitment to embracing decentralized trials and to changing the culture that has been the rate limiter to innovation.”

“This is an important opportunity for Curavit to collaborate with other DCT pioneers to further our mutual mission of making patient participation more accessible across all demographics,” said Joel Morse, co-founder and CEO of Curavit. “We look forward to sharing best practices, research methodologies, and technologies that will transform how research gets done.”

In other news today, Curavit announced the expansion of its leadership and sales teams (link to release on website) and the doubling of its revenue, indicative of the continued industry wide growth of DCTs.

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs). Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. Current clients include Frequency Therapeutics, Beech Tree Laboratories, Brown University, and Boston Medical Center. For more information, visit www.curavitclinicalresearch.com.

Media Contacts:

Jamie Dabao Brown, +1 (626) 488-0732, jamie@barbadoraink.com

Lisa Barbadora, +1 (610) 420-3413, lbarbadora@barbadoraink.com

Beech Tree Labs selects Curavit Clinical Research for fully virtual COVID-19 clinical trial

Sept 18, 2020
Curavit Clinical Research - Press Article
Curavit chosen for expertise in decentralized trial design and execution.

Beechtree Labs has chosen Curavit Clinical Research for a fully decentralized clinical trial to investigate a promising Covid-19 therapy. The FDA-authorized phase 2 clinical study will evaluate the effect of Beech Tree’s BTL-TML therapy on mean duration and severity of disease in 40 outpatients aged 60 years or older with underlying conditions. The study also assesses the safety of BTL-TML over 10 days of treatment and an additional four days of follow-up.

The trial is unique in that it is a fully decentralized clinical trial, made possible by applying virtual trial design protocols, digital telehealth technologies, electronic patient reported outcomes (ePRO), and full web and contact center patient support to eliminate the need for in-person office visits.

Thomas Hatch, Director of Business Development at Beech Tree said: “We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.” Joel Morse, CEO of Curavit added: “This is a unique opportunity to apply modern trial design and telehealth
technologies to allow patients to participate in this study without the potential risk of traveling to physical sites and to participate from the safety and comfort of their own homes.”

ABOUT CURAVIT

Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” – clinical trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social
engagement information, and leverages leading telehealth, patient data platform, and medical device technologies. Connect: https://www.linkedin.com/company/curavit/
Follow: https://twitter.com/CuravitClinical

ABOUT BEECHTREE LABS

Located in Providence, RI, Beech Tree Labs, Inc. (BTL) focuses on the discovery and early development of therapeutic agents that address a spectrum of unmet medical needs. The company has an extensive portfolio of patented formulations for products intended to treat such disorders as urinary incontinence, allergies, benign prostatic hypertrophy, anxiety, chronic obstructive pulmonary disease and herpesvirus infections. BTL has conducted over 15 FDA- authorized phase 2 trials and has out-licensed both technology and products.

LEARN MORE ABOUT THIS STUDY

The current FDA-approved Phase II pilot study is taking place in Draper, Utah at Intermountain Clinical Research. Additional sites will open in the future. To learn more about this study:

● You or your doctor may contact the study research staff ( deann@icrtrials.com ) or call
833-358-3784.
● Visit the study website: https://www.sickwithcoronavirus.com/
● You can also visit clinicaltrials.gov, the U.S. National Library of Medicine database of clinical studies conducted around the world. ClinicalTrials.gov identifier (NCT number): NCT04522830

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer, Curavit
info@curavitclinicalresearch.com

Curavit Clinical Research and eMoyo USA, LLC Partner to Deliver High-Quality Home-Based Audiometric Data for Virtual Clinical Trials

Sept 9, 2020
Curavit Clinical Research - Press Article

New solution allows patients to participate in clinical trials from the comfort and safety of their own homes.

Curavit Clinical Research, a virtual research organization, and eMoyo USA, LLC, the USA representative of eMoyo, a global leader in healthcare technology, today
announced a partnership to pave the way for hearing research studies to continue
during the COVID-19 pandemic. Curavit’s virtual team of audiologists remotely monitor the hearing of research subjects in their homes using the eMoyo KUDUwave™ Pro boothless audiometer. This portable, high-frequency audiometer enables a booth-free operation and extended high frequency hearing test up to 16 kHz, making the KUDUwave™ Pro the ideal solution for virtual or hybrid clinical trials which require audiology end points.

“With KUDUwave™ boothless diagnostic audiometers we can now test patients in their homes without compromising on the quality of testing and without having to transport and maintain an audiometric booth. Given COVID-19, this provides a lower health risk for the study subjects, as the soundbooth could be a source of cross contamination.” says Grant Talbot, of eMoyo.

Prior to every planned audiology test date, a Curavit Study Team member sends a
pre-configured laptop and a KUDUwave headset to each study subject’s home. Working directly with the study subject, a Curavit audiologist initiates a telemedicine visit where they perform a thorough, high quality audiometric evaluation. The final data is securely transferred to the Curavit Study Team, where it is stored in a secure and validated system.

“With this unique technology, teamwork, and our proprietary protocols, a clinical trial subject performs a comprehensive hearing test in less than an hour, all from the comfort of their home,” said Dr. Pam Diamond, Otolaryngologist, co-founder and Chief Medical Officer of Curavit. “KUDUwave combines the audiometer, headset and required components into a single, portable, lightweight device weighing only half a pound and it is controlled remotely by our audiologists using a laptop and telemedicine software. This process may shorten the trial timeline, and minimizes the potential for trial disruption due to COVID-19.”

“We are honored to partner with eMoyo and to work together to bring these
best-in-class offerings to virtual and hybrid clinical trials. Though catalyzed by the
coronavirus pandemic, this solution makes participation in these types of trials far easier for many more patients, regardless of where they live, work and study; thus ensuring richer data and better research outcomes well into the future.” says Dave Hanaman, Chief Commercial Officer and co-founder of Curavit.

About Curavit Clinical Research

Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social engagement information, and leverages leading telehealth, patient data platform, and medical device technologies.
https://curavitclinicalresearch.com/

About eMoyo

eMoyo is a team of passionate designers, engineers, clinicians and dreamers working to make the world a better place, by creating the technology that gives the world access to quality healthcare. This includes advocating for policy change, health implementation science and the development of technology that empowers healthcare providers to reach further and do more. Founded by Dr Dirk Koekemoer, eMoyo is an ISO13485 company renowned for producing high quality, innovative technology and services. https://emoyo.net/

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer, Curavit
info@curavitclinicalresearch.com

https://emoyo.net/

https://emoyo.net/

Curavit Clinical Research officially launches with a focus on virtual trials

Feb 18, 2020
Curavit Clinical Research - Press Article

Industry veterans Joel Morse and Dave Hanaman announce the formation of a company to lead into the future of clinical trials.

Curavit was founded to help realize the potential of decentralized trials. Mssrs. Morse and Hanaman come to Curavit with over twenty five years of experience, founding, building, and running successful technology-enabled healthcare companies. https://curavitclinicalresearch.com/about

● The $70 billion global clinical trials market continues to grow , while the success rate of trials continues to decline, often due to lack of enrollment and participation by patients and doctors.
● New technologies and new approaches offer an opportunity to both increase success rates and decrease the costs of traditional clinical trials.
● Virtual clinical trials take advantage of these trends and opportunities.
● Just a small percentage of trials today, virtual trials are projected to increase geometrically due to their advantages.

“Curavit is the result of our desire to solve growing challenges to the important work of drug discovery.” said Joel Morse , Chief Executive Officer and Co-Founder of Curavit. “By combining experience, technology, and solid execution, we will bring cutting-edge research to previously untapped and underserved patient populations.” Chief Commercial Officer and Co-Founder Dave Hanaman added:
“We are fortunate to have worked with some of the most respected companies and visionary people in the life sciences industry, and are honored by the support we are receiving from them for this effort.”

ABOUT CURAVIT

Curavit Clinical Research takes a clean sheet approach to clinical trial design and execution. Optimized on a new “virtual” – or decentralized – model, the company supports patients’ participation from wherever they live, across the country, and around the globe. Curavit teams with distinguished principal investigators in specific therapeutic classes, works from archetypal investigational sites in major research hubs, leverages best-in-class industry standard patient data platforms and mobile health devices to collect, manage and protect patient data. By applying advanced data analytic algorithms to patient information and real world evidence, Curavit partners with healthcare entities to identify, qualify, and enroll patients in approved clinical trials. Curavit plans to open its first site in Boston this summer.
Connect: https://www.linkedin.com/company/curavit/
Follow: https://twitter.com/CuravitClinical

MEDIA CONTACT

Dave Hanaman, Chief Commercial Officer
info@curavitclinicalresearch.com