Diversity of Participants in Clinical Trials

The Diversity of Participants in Clinical Trials Initiative provides tools and information to organizations working to improve the representation of diverse patient populations in clinical trials so that trial demographics include the same populations for whom the studied drugs are intended to be prescribed.

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

Available Solutions

For more information and to explore our solutions, visit our Initiative Solutions page.

Related Initiatives

Patient Experience

The Patient Experience (PE) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.

Clinical Research Awareness

Clinical Research Awareness seeks to educate the public about clinical research and encourage conversations about clinical trials between patients and their health care providers.

Clinical Research Access & Information Exchange

Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.