Remote Clinical Trial Enrollment Program Is Valuable in the Face of COVID-19

Conventional recruitment and outreach events often involve direct contact with potential participants during memory clinics, brain health check-ins, or health fairs. The traditional clinical trial prescreening process often requires a potential participant to travel to a research site for an initial appointment. However, in the face of COVID-19, many elements of clinical trials are moving toward a remote design.

The Global Alzheimer’s Platform Foundation® (GAP) is developing a program intended to make prescreening and recruitment events more accessible to potential Alzheimer’s disease (AD) clinical trial participants. Information about the program was presented at the 13th Clinical Trials on Alzheimer’s Disease Congress 2020.

GAP’s proposed multipronged strategy contains several elements designed to engage potential participants, enable prescreening, and maintain relationships with the community. Some of these programs include remote recruitment toolkit, virtual prescreening toolkit, home visit to-go kit and phlebotomy certification, and education on billing opportunities for cognitive testing.

Program implementation began late in the second quarter of 2020 in different venues. Initial outcomes include more than 800 attendees at 12 virtual talks, 100 prescreens and 13 screens at a single site, 92% of GAP-Net sites in one GAP-enabled trial have successfully converted some or most of their processes to be virtual, and a Centers for Medicare & Medicaid Services billing method was implemented on a small scale at one site.

GAP-Net sites can effectively recruit and prescreen in a remote and virtual environment when provided information, support, and resources,” the researchers wrote. “Additional opportunities for more advanced programing may be included for support on specific trials, including kits to facilitate home health visits, where appropriate and approved. GAP’s Remote Recruitment and Prescreening Program will provide the field with several benefits. A mechanism for remote prescreening will allow sites to continue to prescreen while protecting the health and safety of the clinical trial community. The remote prescreening process will help offset delays experienced because of the COVID-19 pandemic. Finally, the program will provide much needed liquidity to AD clinical trial sites.”

Presentation: P101: Reinventing Alzheimer’s Disease Prescreening: The Global Alzheimer’s Platform Foundation® (GAP) Remote Recruitment and Prescreening Program. Presented at the 13th Clinical Trials on Alzheimer’s Disease Congress 2020, Nov. 4-7, 2020.