CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Jeff Pohlig, vice president, U.S. Operations for Compass Research, which is part of the Bioclinica Research Network. Compass Research, which has three locations in Central Florida, was a finalist for the Society for Clinical Research Sites’ 2016 Site Patient Recruitment Innovation Award (SPRIA), which recognizes research sites that have developed and implemented innovative patient recruitment programs.
Q: Tell us about how you offered free mobile memory assessments to help educate the community about Alzheimer’s disease and identify potential volunteers for neurology studies.
A: The mobile memory screening center is a way to connect with new patients in the community, particularly those who are unfamiliar with clinical trials. Connecting person-to-person in community events helps patients overcome some of the skepticism or fear they may feel about clinical trials. When they meet our staff, they get to know us as people and see that we care about the research that we’re doing. The fear melts away. You can’t get that from an advertisement.
The objective of this recruitment tactic was to offer underserved communities a convenient way to access advanced health screenings for early detection of memory loss. Areas in Central Florida with a high-density senior population were targeted with a direct-mail piece educating residents about the prevalence of Alzheimer’s disease and offering appointments for a free memory screening in their neighborhood. The bus was parked in an easy-to-access, well-known location such as a local YMCA or CVS Pharmacy. We received an overwhelming response immediately after the direct-mail piece dropped and the pre-screen appointments on the bus were filled within one day. The bus had two private screening rooms, so we could schedule and pre-screen 34 patients per day. Another 60 interested patients were scheduled for a screening visit at our site since we could not accommodate them on the bus.
Marketing materials were IRB approved and participants signed a pre-screening consent, but the free memory screenings were not study specific. The screening test gave subjects a glimpse of a routine tool used in clinical research, so we talked to them about research in general, and it gave them valuable information about their health status. Clinical research coordinators (CRCs) reviewed the results with participants after the screening. Sometimes the patients went away with just their score. Sometimes we referred them to their primary care physician or recommended a research study, depending on what we picked up from the memory screen.
At the first screening event, 34 patients were scheduled, 27 were pre-screened—which represents a 79.4% show rate—and nine met eligibility for five different Alzheimer’s research studies currently enrolling at our site.
Q: Do you plan to expand the mobile-unit approach? What’s next?
A: We started this for neurology and are running cognitive screenings, but you can do assessments for anything. There aren’t many indications where you couldn’t do a general, quick test to attract people to the bus and then open the possibility for enrollment in a research program.
The approach also could be used for targeting any type of challenging patient demographic and connecting with those patients. It could be an age-related demographic since some of the elderly can’t drive or move about easily. We could use it to engage niche minority populations that are difficult to reach with mass market media or subjects that are farther away from our sites. The NIH and some sponsors are dictating that a certain percentage of enrollment in their studies be from minority populations. By using zip-code targeting, we could send the bus to connect with patients in neighborhoods that have a heavy minority population.
Because of regulatory issues, we limited our program to pre-screening, but we are working on how we might be able to expand the approach. There would be more regulatory hurdles with having a mobile site since the FDA 1572 form that investigators sign is approved for a specific address. We are looking at whether there is a way to get the bus approved as a location. The facilities inside the bus—the exam rooms and the staff—would all be certified and would be the same as for studies conducted in a fixed building. Instead of patients coming to the research center, the research center could travel to the patients. There isn’t opposition to the idea, but it would take more conversations with the sponsors and IRBs.
Q: Would it be difficult for other sites to implement a similar mobile-unit screening program?
A: It wouldn’t be difficult to reproduce. We worked with a company called HealthFair, which partners with organizations across the country to offer mobile health screenings. It’s just doing what you normally do at your site on a bus. We did it initially as a test. Now we are working to set up a program where we can do it on a consistent basis. We try a lot of new things and not all of them work. But when we find one that does, it’s exciting to add it to our toolbox of ways to recruit.
This article was reprinted from Volume 21, Issue 05, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »