A clinical trial recruitment guide for investigators

Recruitment is one of the greatest challenges — and opportunities — for researchers. Reaching potential participants for clinical trials has always been a complex process, and the COVID-19 pandemic made those issues even trickier.

UB Clinical and Translational Science Institute (CTSI) faculty and staff are available for consultations and guidance, and a wide variety of tools to enhance recruitment and retention are offered online. Recruitment assistance can be provided to UB investigators and Buffalo Translational Consortium partners during grant planning, study startup and retention phases.

Given the impact of recruitment on the success or failure of the clinical trial process, CTSI Director Timothy F. Murphy, SUNY Distinguished Professor and senior associate dean for clinical and translational research in the Jacobs School of Medicine and Biomedical Sciences at UB, encourages investigators to take full advantage of CTSI offerings.

“One of the most important bottlenecks in the translational pipeline for bringing new innovations to health  care is recruitment to clinical trials,” Murphy says. “A total of 75% of clinical trials are not completed due to failure to reach recruitment goals. That’s why the CTSI has placed an emphasis on providing expertise and support to research teams for recruitment to clinical trials.”

In addition, Murphy says the CTSI’s Community Engagement Core and Recruitment and Special Populations Core can provide specialized guidance on engaging populations traditionally underrepresented in research.

“Less than 10% of participants in clinical trials nationally are persons of color,” Murphy explains. “That means that as a nation, we are depriving large parts of our population of the benefits of participating in clinical research and access to the latest advances in health care. It is critical that we include participants that represent our community in clinical trials. Our CTSI recruitment team places great emphasis on that priority and has expertise and tools to assist research teams.”

Ashley Regling, CTSI clinical recruitment coordinator, works closely with investigators to analyze their needs, assist with preparation of research materials and identify next steps.

“We offer a wide range of services, such as developing strong recruitment plans for grant proposal submissions, publicity materials for studies, community-friendly language study descriptions, and creative solutions to address recruitment and retention challenges,” Regling explains.

“The best time to request a recruitment consult is when you are planning your study,” Murphy notes. “This can impact the design of your study and, importantly, helps with buy-in from the population who will participate in the study.”

The recently redesigned CTSI Recruitment Resources Toolkit, a page on the CTSI website, provides investigators with a variety of links, guidance and materials, including:

• Online study listings, including the UB Participate in Research portal and ClinicalTrials.gov.
• Participant databases, including the Buffalo Research Registry, ResearchMatch, i2b2 and TriNetX.
• Information about CTSI consultation services, including the CTSI recruitment team, Community Engagement Core, Special Populations Core and BERD (Biostatistics, Epidemiology and Research Design) Core.
• Details on study resources, such as prepaid debit cards for research participants, REDCap and the Trial Innovation Network
• Templates for recruitment flyers, UB branding tools, information on social media advertising, services from UB’s Institutional Review Board (IRB) and image databases.

“Our toolkit is a great resource for everyone, from early-stage faculty to seasoned researchers,” Regling says. “Study teams are encouraged to reach out for assistance in using the tools, and to check back frequently for new and improved materials in response to an evolving clinical trials process.”

Tania T. Von Visger, assistant professor in the School of Nursing, sought assistance with recruitment on her 2022 CTSI Pilot Study titled “Piloting an Evidence-based Mobile Mindfulness Practice to Support Self-Management Among Underserved and Racial Minority Adults with Pulmonary Hypertension.”

“Because my pilot study aims to test mindfulness-based intervention among the rare patient population with pulmonary hypertension, the CTSI Recruitment and Special Populations Core have been instrumental in getting me started on the project and helping to modify and improve the recruitment approach of research participants,” Von Visger says. “Qualified recruitment specialists were eager and ready to meet and discuss strategic plans that are feasible and in adherence to Good Clinical Practice guidelines.”

Von Visger’s consultation with the CTSI team was particularly helpful when navigating the IRB process.

“As a new researcher to UB, the assistance with the IRB submission preparation and identifying additional potential recruitment avenues is invaluable,” she says. “This ongoing support will help research investigators to achieve recruitment goals toward the successful completion of a clinical study.”

To get started, study teams are encouraged to reach out to the CTSI to schedule an individualized consultation.

“We offer these either in person or via Zoom, and use this time as a way to plan strong recruitment strategies, identify creative recruitment strategies and troubleshoot any existing recruitment or retention issues,” Regling says.

Interested researchers can access the CTSI Recruitment Resources Toolkit online   and request a consultation through the CTSI service request portal, or by contacting Ashley Regling at 716-645-1327 or amrupp@buffalo.edu.