Blog Post

New FDA Guidance on Enhancing the Diversity of Clinical Trial Populations, and some great related resources

December 7, 2020

The FDA recently published a new guidance on diversity in clinical trial populations, which “recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.” The document may be found and downloaded from the FDA website: here.

In addition to providing guidance on eligibility criteria, enrollment practices, and trial designs, the guidance notes, “Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved. As we all know, however, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials.”

To help address these ongoing challenges, Rho has been making increasing efforts to alert sponsors to the need for increased inclusion of underrepresented populations in clinical trials, as well as to help facilitate enrollment of these populations once the studies are underway. Our teams have helped sponsors increase diversity in their trials, including increasing diversity in a clinical trial for Alopecia (read the case study).

Additionally, below are some excellent resources for learning more about the importance of diversity and inclusion of representative populations in clinical trials, as well as guides, toolkits, and other reference materials to help with supporting and operationalizing our collective efforts to achieve this.

Racial Equity Impact Assessment Toolkit:

NIH Scientific Workforce Diversity Toolkit:

Center for Information and Study on Clinical Research Participation (CISCRP):

Multi-Regional Clinical Trials Center (MRCT) Guide and Toolkit:

The Boston Medical Center Patient Navigation Toolkit:

Establishing Effective Patient Navigation Programs in Oncology Workshop Proceedings:

National Cancer Institute Center to Reduce Cancer Health Disparities (CRCHD):

American Cancer Society Patient Navigator Program (for patients):

American Cancer Society Patient Navigator Program (for professionals):  

*Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA:

*webcast to air on 12/16/20

Jack Modell, Vice President and Senior Medical Officer, is a board-certified psychiatrist with over 35 years of experience in clinical research, including 20 years conducting trials, teaching, and providing patient care in academic medicine, and 15 additional years of experience in clinical drug development (proof of concept through market support), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management within the pharmaceutical and CRO industries. Jack has authored over 50 peer-reviewed publications across numerous medical specialties and has lead several successful development programs in the neurosciences. Jack is a key opinion leader in the neurosciences and is nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.