February 1, 2023
Getting clinical trials to the finish line is not easy. Between 15% to 40% of patients, depending on the trial phase, drop out before a trial is completed, according to Atlant Clinical. And 11% of trials fail to enroll even a single patient, according to Advarra. That’s not to mention the significant diversity problem. According the FDA’s 2015-2019 Drug Trials Snapshots Summary Report, 76% of all clinical trial participants are white. So, there is plenty of room for improvement across the board to make clinical trials more accessible, diverse, and easier on patients, which starts with increasing awareness.
“Aside from the obvious trust factor that permeates throughout clinical trial recruitment, awareness is the other major contributing factor in the underrepresentation of diverse populations in clinical trials,” explains Mo Hamzeh, SVP, Management Supervisor, Ogilvy Health. “Some patients might be willing to participate if they are aware not just of the clinical trial itself but also of the benefits that come with it. This lack of awareness among patients might also be a direct reflection of the biases that investigators have when seeking patients who may be eligible to participate in clinical trials.”
One way companies can address these potential biases and increase awareness within marginalized groups is to include trusted community members in the process.
“It’s about making the neighborhood doctor a key opinion leader who can educate and inform within the community,” says David Fleishman, Chief Operations Officer, BBK Worldwide. “It’s about selecting the right location for the study site—not because there is a high patient population, but because it is an area where patients are going to be more comfortable about pursuing the care they need. And it’s about ramping up support services that address some of the common concerns that may interfere with participation, such as childcare, meal preparation, transportation, and lost wages.”
Decentralized clinical trials (DCTs), which involve utilizing technology like telehealth or remote patient monitoring as well as local healthcare services to bring trials to the patients, may also be helping in this regard.
“In a recent research project we conducted with Underscore Marketing exploring the importance of HCP-based clinical trial recruitment and critical success factors, I was encouraged to hear a repeated focus on the opportunity to use DCTs to reach both a greater number of patients and a more diverse cohort during interviews with pharmaceutical decision makers from Genentech and Otsuka,” says Christine Franklin, Executive Director, The DHC Group. “Since DCTs will produce patient claims data that will better match the real-world patient population, we are also looking forward to the resulting impact on the ability of marketers to create better and more authentic cross-cultural marketing campaigns.”
The Rise of DCTs
Patients in general are intrigued by the potential of DCTs and their ability to make participation easier on them. According to Ivor Clarke, CEO, SubjectWell, surveyed patients who were “very interested” in participation jumped from 39% to 60% when told the trial could be completed entirely at home. However, he warns that with DCTs comes a significant trade-off.
“In addition to needing reliable WiFi, a supported device, and the necessary skills to use it, patients are too often forced to navigate complex workflows on their own,” Clarke explains. “This has the potential to exclude certain demographics without sponsors and investigators realizing it. For example, SubjectWell surveyed Parkinson’s disease patients about their comfort with digital tasks and found that while 97% of patients 59 and younger were ‘very comfortable’ with a digital questionnaire, only 31% of patients 80 and older shared the same level of comfort.”
For that reason, Dr. Clare Grace, Chief Patient Officer, Parexel, says to expect a more hybrid approach to clinical trial design in 2023 that allows sponsors to meet patients where they are—both geographically and in their treatment journey.
“Every patient and trial are different, and we must recognize patients’ needs and wants to create a model that eases their participation burden,” Grace says. “This means recognizing not all patients want to participate in a fully DCT and prefer having an in-person component. Conversely, other patients may prefer participating in trials from the comfort of their own home or in their local community.”
Other Considerations for Better Trials
Patients who are skeptical of participating in trials would also like greater ownership over their data as well as the ability to continuously control access to it.
“Blockchain technologies that enable self-sovereign identity governance must be integrated into every aspect of trials, from patient recruitment and consent through to submission,” says Dave Hanaman, Co-founder, President, & Chief Commercial Officer, Curavit Clinical Research. “When patients have control of their data—not just vague ‘empowerment’ granted from a monolithic company—they will have confidence in the system because in a real sense, they will own it.”
Speaking of data, historical real-world data can also help improve the efficacy and safety of clinical trials.
“Computational disease models allow us to conduct synthetic trials on an AI platform, rather than in the clinic,” says David Harel, Co-Founder and CEO, CytoReason. “We can compare the efficacy of one drug across multiple diseases or compare multiple drugs head-to-head. The technology can help pharma and biotech companies plan their clinical trial strategies and potentially shorten trial phases, reduce development costs, and increase success rates.”
To improve patient screening and trial enrollment, Carla Balch, CEO, Spesana, says physicians crave being more involved in trial design.
Balch says, “Pharma can give physicians an opportunity to contribute intelligence by integrating collaboration into platforms designed to address the challenges physicians have identified, encouraging: 1) open discussions as inclusion/exclusion criteria is developed; 2) providing sponsors understanding of the infrastructure and standardized processes required to enable clinical trials to be as smooth a treatment process as is the standard of care; and 3) better alignment of trial criteria to more accurately represent clinical and operational behaviors inside the halls of medicine.”
Some sponsors are also using agile methodology or adaptive clinical trials to reset trial designs and parameters based on insights from the collected data.
“First developed in the software industry, agile transformation allows cross-functional teams to shift quickly,” explains Sukhwinder Kaul, Senior Manager-Clinical Insights, Axtria. “By using continuously updated analytics, sponsors or contract research organizations can refine sample size, identify sites/investigators that generate more value and focus recruiting efforts on them, and stop a trial early if it becomes clear it is unlikely to demonstrate effectiveness. Such insights can successfully define the course of a trial and shorten a product’s time to market, which is the ultimate goal of any trial.”