Clinical trials should reflect the population most likely to use the drug undergoing testing should it be approved. Unfortunately, there is an ongoing issue of diversity in participants of clinical trials in the United States.
The U.S. Food and Drug Administration (FDA) has promoted enrollment practices that should lead to clinical trials that better reflect the overall population, primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials.1
More male than female subjects are included in clinical drug trials as research participants. Representation from minority groups of Black and Asian people in clinical drug trials has increased over the last 20 years, but Asian and Native Americans are still underrepresented. Increased representation from minority racial groups is essential as more robust representation can lead to increased efficacy and safety in minorities.2
Selecting a location for clinical trial research is often based on access to specific equipment, physician expertise, and/or sample patient populations. There are strategies that researchers and organizations can use to ensure a more inclusive and representative participant pool in clinical trials, ultimately improving the impact of research findings on diverse populations.
Trial sponsors need to build relationships with local community organizations, churches, and cultural groups to establish trust and collaboration. One way is to conduct workshops and informational sessions to educate communities about the importance of clinical trials, dispel myths, and address any concerns.
Researchers and healthcare professionals should undergo training programs focused on cultural competence, sensitivity, and awareness of diverse healthcare beliefs and practices. This would help them provide translated study materials and offer language interpreters during the recruitment and participation process.
Clinical trials should provide transportation assistance or partner with local transportation services to overcome barriers related to travel. Some trials offer compensation for time and travel expenses.
A clinical trial should publicly report demographic information of its study participants to demonstrate a commitment to transparency and accountability. Trial sponsors should also provide regular updates on the enrollment progress, highlighting efforts to improve diversity.
Unity Trials was created to help address these issues. That's why when you work with one of our Trial Navigators, we can help find your ideal clinical trial.
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. November 2020. Accessed April 25, 2024. www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
Sex, racial, and ethnic diversity in clinical trials. March 2023. Accessed April 25, 2024. www.ncbi.nlm.nih.gov/pmc/articles/PMC10264921
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