FDA Offers Guidance to Enhance Diversity in Clinical Trials

December 02, 2020 by Alec Stone MA, MPA, ONS Government Affairs Director

The COVID-19 coronavirus continues to smother the United States, and nationwide efforts to flatten the curve aren’t lowering cases or preventing deaths. U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, an oncologist by training and profession, addressed the actions needed to combat COVID-19. One in particular is ensuring that clinical trials accurately reflect diverse populations.

“Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to healthcare disparities,” Hahn said. “One important step that researchers and medical product sponsors can take to confront healthcare disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations.”

In November 2020, FDA released its recommendations on how product sponsors can improve clinical trial diversity by accounting for logistics and other participant-related factors that could limit participation.

FDA’s “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs” provides recommendations for inclusive trial practices, trial designs, and methodologic approaches, including:

“To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product,” Hahn said.  

Oncology nurses serve an important role in a patient’s access to and enrollment in clinical trials. Patients with cancer trust oncology nurses and often feel comfortable opening up about the obstacles they face. Have conversations about unequal access clinical trials, use that information to help reform the system, and encourage patients to consider the potential benefits of trial participation.


Copyright © 2020 by the Oncology Nursing Society. User has permission to print one copy for personal or unit-based educational use. Contact pubpermissions@ons.org for quantity reprints.