12 Jan Association of Clinical Research Professionals’ response to FDA draft guidance on diversity in clinical trials

Increased diversity should be a requirement, not a suggestion.

By Otis Johnson, Diane Anderson Foster, Ruma Bhagat, Nadege T. Gunn, Marissa Hill, Ashley Moultrie, Aida Sabo, and K’Res Starling, The Association of Clinical Research Professionals (ACRP) via the Food and Drug Law Institute (FDLI)

The need for action to improve the diversity of clinical trial participants is increasingly recognized against a backdrop where many trials have historically enrolled mainly white, and mainly male, participants. At the clinical trial site level, pressure is already being felt, with sponsors increasingly requiring details of diversity in both the clinical research organization (CRO) workforce and clinical trial participant pool as early as the request-for-proposal (RFP) stage of an engagement.

Improving diversity in trials is the subject of recent draft guidance document from the U.S. Food and Drug Administration (FDA). Published in April 2022, the document is entitled, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry.” The latest guidance builds on FDA’s seminal guidance on clinical trial diversity, “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry,” published in November 2022.

This paper provides viewpoints on the April 2022 draft guidance and on pathways forward from experts with extensive day-to-day experience of the realities of running clinical trials. Read more …