Insights

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taken steps to address these disparities in clinical trial study enrollment over the past two decades, including recent draft guidance issued in June 2024, which mandates diversity action plans for all Phase II and III registrational studies.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.

For too long, clinical trials have failed to adequately represent the diverse patient populations that will ultimately take the drugs and treatments being tested. This has created gaps in understanding how different people may respond to therapies based on factors like age, gender, race, and ethnicity. The lack of diversity in clinical research means medicines are not studied in representative populations, which can negatively impact healthcare decision-making and patient outcomes.