Decentralized Trials Part 2

Day 2 of the Reagan-Udall Foundation for the FDA’s public meeting on decentralized trials opened (very early!) with a presentation from Otavio Berwanger, MD, PhD, Executive Director at The George Institute for Global Health.  He started by making the case for using decentralized trials to increase the number of patients in a patient population enrolled in clinical trials as well as improving diversity in age, race, disease severity, and co-morbidities. He noted that, on average, participants travel 67 miles to study sites.

Dr. Berwanger reviewed key processes and technologies that enable decentralized trials.  These measures start with on-line participant recruitment tools and continue with electronic informed consent; direct-to-patient investigational product shipment; home health visits; and connected devices for data collection. A mobile clinical trials unit…  Simplifying processes and technology also supports these types of trials. The George Institute’s EVOLVE-MI trial minimized eCRF entry by collected data in electronic source, utilized local laboratories for baseline, minimized lab collection, and used a hybrid EDC/IRT system, eliminating at least one logon for the sites. He cautioned that the purpose of technology is to increase participant engagement; technology and processes should adapt to the participant.

Noelle Cocoros, DSc, MPH, Principal Research Scientist at Harvard Pilgrim Healthcare Institute and Principal Associate in Population Medicine at Harvard Medical School on lessons learned from trials embedded in US health plans.  These trials use insurance claims data to identify potential subjects and conduct all or part of the analyses. Because insurance data includes information on all patient encounters, medications, and hospitalizations, it presents a trove of real-world data that can also be used for analysis.

Dr. Cocoros advocated maximizing engagement from stakeholders, in this case health plan management. Using a centralized IRB simplifies regulatory submissions.  When identifying prospective participants using large data sets, she recommended using validated algorithms.

Adrian Hernandez, MD, MHS, Cardiologist, Vice Dean and Executive Director of Duke Clinical Research at Duke University School of Medicine, discussed the patient experience of participating in a clinical trial. He shared his experience of participating in a COVID-19 study, where his commitment to the visit schedule was impeded by traffic and other obstacles. He shared some lessons learned from the ACTIV-6 trial in COVID-19 patients.  He described the approach as “click and mortar,” engaging participants in whatever scenario – on-site or remote – where they felt most comfortable.  Whereas some participants are computer savvy, others don’t have the internet infrastructure, have privacy concerns, or prefer to attend an office visit.  The trial enrolled more than 7700 participants from 93 sites in all 50 US states. He echoed Dr. Berwanger’s sentiment that technology should be selected to facilitate the goals of the study and patient engagement.

The organizers disabled the chat for this session, so the Q&A focused more on the themes of patient engagement and practical application of technologies that were raised in the initial presentations.