Planning For Diversity

By Rachael Fones, Director, Government & Public Affairs and Strategic Advisor, Diversity in Clinical Trials at IQVIA

Efforts to make clinical trials more diverse received a potentially game-changing boost from the US Food and Drug Administration (FDA). In April 2022, the FDA released another guidance on diversity in clinical trials – this time with a clear focus on upfront planning and goal setting earlier in development.

The draft guidance, entitled Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials, expands on an existing but lesser-recognized 2016 recommendation that sponsors submit a Race and Ethnicity Diversity Plan for discussion before starting Phase III.