Clinical trial sites that offer their study volunteers travel-related reimbursement and services, translated documents and translator services, and adequate compensation can have the most impact in terms of achieving diverse enrollment of participants, according to a new survey by a quartet of clinical researchers.
As described in “Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion,” published recently in the journal Clinical Pharmacology & Therapeutics, the survey results include input from 149 clinical research professionals in a wide range of therapeutic indications, mostly employed at large academic medical centers in the U.S. Midwest and Southeast.
Lead author Demi L. MacLennan, MS, CCRA, ACRP-PM, a project manager with Labcorp Drug Development, crafted the paper with her coauthors while earning a master’s in translational pharmacology from The Ohio State University last year.
“Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve,” MacLennan says. “Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. We surveyed site-level clinical research professionals because they have unique insights on diversity improvement strategies for clinical trial enrollment.”
The survey covered site-based current diversity practices; participant compensation policies; use of decentralized clinical trial services, translations, and flexible site hours; and study team factors.
“For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment,” MacLennan notes. “Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we found that providing travel reimbursement and services, translated documents and translator services, and adequate compensation were most impactful on diverse enrollment.”
The authors write that their analysis suggests a multistakeholder approach is necessary to enhance diversity and inclusion (D&I) of study participants. Besides large-scale solutions such as countering community distrust, actionable steps are needed by sponsors and study sites to improve D&I of trial participants, they note.
“Study leadership at the sponsor, contract research organization (CRO), and site-level should create diversity plans prior to study start, and CRO and sponsor budgets should consider D&I strategies during study planning that will target the areas we found to be most influential on diversity in enrollment,” MacLennan says.
Join Demi at ACRP 2023 [April 28 – May 1; Dallas, TX], where she—and two co-presenters—will delve into these survey results to understand barriers to recruiting diverse participant populations and share insights that may influence practice change. View complete schedule.
The survey also touched on diversity among site staff themselves, finding that 7.6% of respondents reported that the racial and ethnic mix of their study staff “lacked diversity” and 25% reported “minimal diversity.” Regionally, perceptions of low diversity (“no diversity” or “minimal diversity”) in staff were greater in the Midwest (42.5%) compared to other regions (18.3%).
MacLennan’s coauthors on the paper are Jennifer L. Plahovinsak, MS, DABT, director of the MS program in translational pharmacology and an assistant professor–clinical in the College of Pharmacy at The Ohio State University; Rob J. MacLennan, MS, a graduate assistant in the Applied Neuromuscular Physiology Laboratory at Oklahoma State University; and Carolynn T. Jones, DNP, MSPH, CRN-BC, FAAN, professor of clinical nursing in the College of Nursing, director of the Master of Clinical Research online degree program, and co-director for workforce development for the Center for Clinical and Translational Science at The Ohio State University.
Edited by Gary Cramer