JMIR Publications

ABSTRACT

Background:

Lack of diversity in clinical trials negatively impacts the generalizability of treatment efficacy across different demographic groups, undercutting safety and equity.

Objective:

As part of a nationwide effort to increase diversity and inclusion in clinical trials starting in 2022, the American Heart Association funded a collaboration between Stanford and Morehouse Schools of Medicine - the Trial Of siTes to increAse diversity in clinical triaLs (TOTAL) Project - to compare recruitment strategy impacts on enrollment.

Methods:

Clinical trials were randomized to one of four recruitment strategies (community ambassador, social media ads, registries, or usual recruitment). The Stanford Lightning Report rapid qualitative approach was employed, involving interviews with principal investigators (PIs) and trial staff at baseline, three months, and trial completion to gain intervention insights.

Results:

Participants were supportive of increasing diversity and inclusion in clinical trials, found the platforms user-friendly, valued having an external team to focus solely on supporting recruitment, and some saw improvement in reaching groups outside of their typical participant pool. Sites also noted major barriers: time and resources, local scarcity of diverse populations, lack of language access, restrictive eligibility criteria, and limitations posed by remote engagement. Insights per intervention included: Community ambassador facilitated connections with external networks and increased recruitment of Asian Americans for some trials, depending on local and personal access. Social media ads, after transitioning to the utilization of BuildClinical, pre-screened candidates for the trial teams, and yielded an efficient recruitment process and a manageable volume of eligible candidates. Registries/StudyPages were user-friendly, and sites benefited from registry systems that directly supported outreach, such as sending out emails to candidates. Usual recruitment most often entailed physician referrals, which benefitted from trusted physician-patient relationships, but many sites mentioned they would often exhaust their typical participant pools. Presentation of Lightning Report results to the sites resulted in several key innovations: investment in a virtual community ambassador model with robust tracking (Airtable), and switching from homegrown social media outreach to digital recruitment specialists focused on clinical trials.

Conclusions:

Clinical researchers must continue refining recruitment methods and cultivating inclusive environments to foster participation from diverse populations. To increase diversity and inclusion in clinical trials, financial and human resources are needed, ideally delivered through institutions that can leverage expertise across trials. Embedding rapid qualitative quality improvement projects in ongoing research can provide real-time insights, earlier identification of issues, and immediate amelioration.