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Community engagement is an important step in increasing diversity in clinical trial enrollment. Engagement involves a conversation with members of the community, with a goal of building trust by being of service in ways most important to that community. This should happen long before any discussion about clinical research or a specific trial, meeting individuals where they are and understanding—and helping address—their needs and concerns.  

With a focus on prioritizing patient and investigator needs, the traditional sponsor-contract research organization relationship is evolving to include sites as part of the partnership matrix. This, combined with the increasing adoption of Functional Service Provider delivery models, has made determining the right balance of control and accountability for each party a critical factor in successful outsourcing partnerships.  

As Chief Clinical Trial Officer at Florence Healthcare, Catherine Gregor has the privilege of collaborating with research sites, sponsors, and CROs on the frontlines of clinical trial operations. Every day, she witnesses the dedication and innovation required to bring new treatments to patients swiftly and safely. However, the recent announcement of significant workforce reductions at the U.S. Department of Health and Human Services (HHS) poses a substantial threat to this progress.

Clinical research is a core component of medical progress, enabling the development of new treatments and therapies that improve patient care. Its success isn’t just about scientific accuracy; it largely depends on including a variety of patient groups in the studies.  

Institutional barriers remain a key driver of health inequities based on race, ethnicity, age and gender, particularly in the United States. The U.S. Food and Drug Administration has taken steps to address these disparities in clinical trial study enrollment over the past two decades, including recent draft guidance issued in June 2024, which mandates diversity action plans for all Phase II and III registrational studies. These regulatory efforts are a helpful step, but much remains to be done in this space.