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.
Mounting public scrutiny on health inequities and racial justice has also helped to illuminate the existing disparities in clinical trial representation and to mobilize remedial action. Still, many sponsors and industry stakeholders continue to find it difficult to drive broad and lasting change. TransCelerate’s Diversity of Participants in Clinical Trials initiative will help to accelerate improvements by equipping sponsors and ecosystem stakeholders with the actionable tools and resources needed to improve the diversification of participants in clinical trials, which should ultimately improve patient outcomes.
When the Diversity of Participants in Clinical Trials initiative first launched in 2014, we sought to promote awareness of the need for greater representation in clinical trials and to offer preliminary guidance for sponsors and clinical trial sites to improve diversity engagement and participation. We released guidance on six key areas: diversity awareness, patient engagement, cultural competency, community engagement, IRB insights about reimbursement, and information on how to develop an informed consent short form.
Today, there is industry, social and global acknowledgment of the problem of underrepresentation in clinical trials and consensus around the need for change. As a next step, TransCelerate is working to equip sponsors and ecosystem stakeholders with the actionable tools and resources needed to improve outcomes for the diversification of participants in clinical trials.
The Diversity of Participants in Clinical Trials Initiative is developing solutions to equip sponsors and ecosystem stakeholders with the tools and resources they need to improve outcomes for the diversification of participants in clinical trials. Check out our current solutions on our Initiative Solutions Page under the Clinical Research Diversity Collaboration Hub. They include the following:
- Diversity Community-Based Site Engagement and Capacity Building
- Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT)
- Sponsor Toolkit Portfolio and Program-Level Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT)
- U.S. Regulatory Landscape: Diversity in Clinical Trials
- Reference Table and Landscape of Available Resources
In addition, previously developed sponsor and clinical trial site materials focused on six key areas to help enhance practices and processes for diverse patient participation. The materials are available on our Initiative Solutions page under the Diversity of Participants in Clinical Trials Better Practice Materials section.