Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion.

Abstract

Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. Site-level clinical research professionals (CRPs) have unique insights on diversity improvement strategies for clinical trial enrollment. A survey was distributed to current CRPs working at clinical research sites in the United States to describe current practices and perceptions of the impact these practices have on participant diversity. Subsequently, descriptive quantitative analysis and inductive content analysis were performed. For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment. Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we report travel reimbursement and services, translated documents and translator services, and adequate participant compensation as most impactful on diverse enrollment. 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. 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. Planning should incorporate strategies to improve D&I including adequate participant compensation, translated documents and translator services, and travel reimbursements.