FDA Issues Draft Guidance to Increase Clinical Trial Diversity

FDA recently issued draft guidance to enroll more participants from underrepresented racial and ethnic populations in the United States into trials, expanding overall clinical trial diversity.  

The draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to FDA early in clinical development. 

The best healthcare products work well for people with certain illnesses and from certain groups, providing significant benefits that improve quality of life. Therefore, ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. 

But most recently, FDA’s 2020 data snapshot on diversity and inclusion among trials found that 75% of participants enrolled in trials were White. Among 32,000 patients participating in these trials, just 11% were Hispanic and less than 10% were Black or Asian. 

Barriers to trial access may include mistrust of the clinical research system due to historical abuses, trial design, frequency of study visits, time and resource constraints for participants, transportation, and conflicts with caregiver or family responsibilities. 

Therefore, the  Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative” to support FDA’s efforts to advance diverse participation. The initiative features an ongoing public education and outreach campaign to address some of the barriers preventing various groups from trial participation.  

The initiative addresses these barriers through culturally and linguistically tailored tools and resources, including educational materials in multiple languages, a webpage with public service announcements and videos, social media outreach, stakeholder engagement, collaborations, and partnerships.  

“The US 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,” FDA Commissioner Robert M. Califf, MD, said in the announcement.  

“This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics, and clinical trials,” Califf continued.  

In February, the Biden Administration revived the Cancer Moonshot initiative to expand cancer prevention and detection further and reduce the death rate from cancer by at least 50% over the next 25 years. 

Notably, FDA’s guidance on increasing diversity in clinical trials is aligned with the Cancer Moonshot goals.