November 8, 2022
There’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.
“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.
1. Expert Protocol Design Review: What Can Be Decentralized?
Traditional clinical trials are complex, but architecting a DCT from the ground up is even more complicated. And while nearly nine in 10 sponsors say they use some elements of DCT technologies in their trials, fully virtual trials are still rare. At a recent conference, one top-10 pharma executive said that while more than half of their trial site visits are virtual, no trials are 100 percent virtual.
One reason for this is because designing a DCT protocol requires highly specialized expertise. Sponsors are leaning into the decentralized approach to speed patient recruitment, increase access and diversity, improve efficiency, and capture real-world data, but are still developing protocol designs within a traditional framework. Expert DCT protocol designers, however, review trial designs to determine what aspects can be decentralized (and which cannot) and the best way to decentralize those elements. They factor DCT considerations into the process from the beginning, instead of shoehorning digital elements into the trial later or superimposing them over traditional designs.
The best resources are experienced in clinical research, the therapeutic area of the trial, and DCT technologies. These experts know how to allocate the right DCT resources to allow for maximum patient flexibility during the trial. For instance, a lot of calendaring is often involved in planning a DCT since the patient is not tied to a specific location. It becomes critical to ensure that there are enough calendar slots for televisit appointments at optimum times for patients. A DCT protocol design expert will take all resource considerations into the design, thinking ahead about what can be done by a coordinator instead of by a clinician or registered nurse and other ways to optimize staffing.
2. Patient Solicitation Partners: Recruit, Screen, Consent, Enroll
Patient recruitment is notoriously time-consuming, but many technology-enabled firms leverage solutions specifically for a DCT. For example, one patient recruiting firm targets potential patients on digital channels using sophisticated targeting, patient-centric recruitment, and technology. Once a patient clicks on an ad, they are taken to a self-service landing page with more info about the trial and self-screening questions. If the patient passes, they can immediately schedule a live screening call, eConsent, and enroll in the trial.
One virtual CRO specializing in DCTs collaborated with this patient recruiting firm on a trial of an investigational DTx for chronic cardiovascular disease. Through targeted ads on key digital channels (i.e., Google, Reddit, Facebook, Instagram), the CRO recruited 50 patients in 10 days, surpassing the sponsor’s originally estimated four-week timeline. In addition, 39 percent of patients who clicked on an ad completed the pre-screen form – again, beating a projected 24 percent completion rate. In total, the CRI and the patient recruiting firm recruited, consented, and enrolled 150 patients in just 58 days.
“Most recruitment methods miss opportunities to enroll patients, whether in finding the right people or communicating the opportunity correctly. Expert recruitment processes coupled with technology-activated enrollment at the site and CRO levels fill trials faster with less friction,” said Dan Brenner, CEO and founder of the patient recruiting firm. “Digital recruitment allows more patients to be enrolled in the right trials, seamlessly. It breaks down the barriers between patients and studies, increasing access for more patients.”
One independent software company optimizes the use of data to digitally recruit, screen, and consent patients in DCTs. With access to 350 million lives of anonymized medical records globally, and 200 million lives of anonymized claims data in the US, the firm uses a data science-based approach to target patients across a large geography.
“In DCTs, there’s a longer-term opportunity to marry enrollment and operational data to continuously learn and refine the patient recruitment and enrollment process,” said Matt Walz, its CEO. “How else can we use this data to improve trials? For instance, this data could inform protocol development so that sponsors can better assess how inclusion/exclusion criteria might impact enrollment. All this data can improve how we work with patients.”
In the end, whichever partner supports the enrollment process, data must be aggregated on a single platform for a seamless site and patient experience, and as an opportunity for continuous improvement. “DCTs expand access to patients who live a distance from academic centers, but they can also add burden,” Rosenberg continued. “For instance, patients must decide about each visit: Does someone come to their house, do they stop at a CVS [pharmacy], or go to the clinic? It is important to consider the impact of this new experience on patients. DCT technology enables us to survey patients in real time and then find ways to alleviate any unforeseen issues.”
3. Remote Data Capture Tools: From Clinical-Grade Sensors to ePROs
The global remote patient monitoring market is projected to be worth over $1.7 billion by 2027, up 128 percent from 2021, and the increased use of a decentralized approach could push those numbers higher as DCTs require clinical-grade medical devices. Hundreds of devices already exist that capture digital biomarkers including sleep patterns, heart rate, and blood pressure. For example, continuous glucose monitors remind diabetes patients to take their insulin while allowing clinicians to monitor their disease.
In addition to these remote medical devices, DCTs can now incorporate convenient, remote lab testing with an end-to-end health testing platform. By making health testing easy for patients in a DCT, specialized firms help sponsors improve completion rates and likelihood of patient retention for the duration of the trial. One CRO partnered with such a firm for a fully decentralized trial for an investigational digital therapeutic for fibromyalgia. The firm’s health testing solution helped speed enrollment for the 12-week trial by 10 times over a traditional trial model.
“Lab testing is an integral part of most clinical trials but can compound patients’ burden in traditional settings,” explained Pouria Sanae, the firm’s CEO and co-founder. “We reduce friction for patients and sponsors by simplifying the process and streamlining data collection on the back end for DCTs.”
Electronic patient-reported outcomes (ePROs) are another critical remote data capture tool frequently used in DCTs. Look for a partner that is focused on ensuring a frictionless patient experience.
“In a DCT, patients have a larger responsibility to report their experiences even if they can do it remotely. At the same time, there is less in-person bonding where the clinician can get to know the patient’s everyday user experience. That is why it is so important to provide them with not only intuitive interfaces, but also concierge-like support throughout the trial,” Rosenberg explained.
4. Single DCT Platform: Bringing It All Together in the Cloud
So many moving parts in a DCT make it imperative to have a single platform that brings them all together for streamlined data analysis and visibility. “All DCT stakeholders need to have visibility into the entire trial journey and connect into the same system,” added Walz. “We need to provide a single entry point to trial technology regardless of recruitment source for a consistent patient experience and streamlined login for sites.”
An ecosystem of pre-vetted partners with technologies that easily integrate into a single platform can also give sponsors the confidence they need to dip their toes into the DCT pool while saving significant up-front time and money managing complex integrations. Many partnering companies and products have pre-built connectors for industry-leading DCT platforms which can drastically reduce start-up time. For instance, one CRO and its partners have reduced DCT start-up time from 14 to six weeks.
DCTs offer sponsors unparalleled trial flexibility, which is exciting in its optionality but can complicate trial design. Rather than being paralyzed by choice, start with these four fundamental elements, build from there, and remember that there is always more than one way to crack a walnut.