Rationale
Racially and ethnically diverse populations have often been underrepresented in clinical trials, leading to persistent gaps between trial representation and real-world disease burden. Underrepresentation can limit confidence in future approved therapies and could potentially lead to unforeseen consequences among the impacted patient populations. This issue is of heightened importance as the demographic landscape grows increasingly diverse.
The Diversity of Participants in Clinical Trials initiative, first launched in 2014 and relaunched in 2020, seeks to promote awareness of this inequity, offer recommendations related to increasing diversity, equity, and inclusion in clinical trials for sponsors and clinical trial sites to improve diversity engagement across various stakeholder groups, and address underrepresentation of participants in clinical trials.
Benefits
- Illuminate ongoing challenges related to increasing the inclusion of underrepresented and underserved patient populations in clinical trials
- Provide a summary of existing and emerging U.S. health authority guidance related to diversity, equity, and inclusion in clinical trials
- Equip sponsors and ecosystem stakeholders with actionable tools and resources needed to improve the diversification of participants in clinical trials
