When Does a Team Start the Discussion on Inclusion and Diversity in Early-phase Clinical Trials?

Area of Science:

• Drug Development
• Clinical Trials
• Health Equity

Background:

• Clinical trials are essential for evaluating drug safety, efficacy, and side effect profiles compared to existing treatments.
• New therapies aim to improve patient quality of life, especially for previously untreatable conditions or by offering better alternatives.

Purpose of the Study:

• To highlight the necessity of incorporating diversity into early-phase clinical trials (Phase I and II).
• To advocate for broader inclusion of racial and ethnic minority groups and women in drug development studies.

Main Methods:

• Analyzing the underrepresentation of minority populations in early-phase clinical trials.
• Comparing the demographic makeup of the general US population with participation rates in clinical trials.
• Emphasizing the importance of lived experiences and exposures across diverse populations in trial design.

Main Results:

• Significant disparities exist between the representation of Latino and Black populations in the general US population and their participation in early-phase trials.
• In 2023, Latino and Black individuals were underrepresented in early-phase trials (6.9% and 7.1% respectively) compared to their population share (18.7% and 12.1%).
• Acknowledging that diverse backgrounds can influence disease experience necessitates exploring these differences in all communities.

Conclusions:

• Calls for earlier collaboration and discussion on diversity inclusion in clinical studies.
• Encourages key opinion leaders and study personnel to move beyond including diversity solely in pivotal (Phase III) trials.
• Promotes exploring solutions for integrating diversity into early-stage drug development.