The FDA has taken steps to increase racial and ethnic diversity in clinical trials with their (draft) guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” which recommends that sponsors develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance. 

The FDA remains committed to increasing enrollment of diverse populations in medical product and drug development and will continue to engage with federal partners, sponsors, and health advocates to reach this important goal.

Given the FDA’s guidance, sponsors are beginning to set diversity expectations and goals.  It is with this in mind that we have created a Research Site Diversity Measures Survey to help identify gaps so that we can work together to fill them.

Site Diversity Survey

Research Site Diversity Measures Survey
*This refers specifically to ethnic background.

Once you’ve submitted the Site Diversity Measures Survey for your site, we will send you a report on your site’s diversity progress and work with STARR Certified Sites to start filling in any gaps identified.

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

The STARR Coalition’s Site Diversity Measures Survey is adapted from the SCRS Diversity Assessment tool, which can be found HERE.