FDA Issues Guidance on Enhancing Diversity in Clinical Trial Participation
The FDA has released comprehensive guidance addressing strategies to enhance the diversity of clinical trial populations, emphasizing the importance of representative participant enrollment to ensure that medical products are safe and effective across diverse demographic groups.
The FDA has issued important guidance on enhancing the diversity of participants in clinical trials. This guidance provides recommendations for sponsors on developing and implementing enrollment practices that ensure clinical trial populations reflect the diversity of patients who will use the medical products. The document addresses barriers to participation, strategies for broadening eligibility criteria, and approaches to engaging underrepresented communities. This initiative aligns with HACT's mission to ensure equitable access to clinical research and to generate data that is representative of diverse populations.