FDA Offers Guidance to Enhance Diversity in Clinical Trials
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:
- Accounting for logistic limitations
- Considering reducing frequency of required visits
- Implementing electronic communications, such as phone, email, or social media to replace site visits
- Broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases
- Increasing inclusion of women, including pregnant women, racial and ethnic minorities, children and young adults, and older adults
“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.