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.

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.

Benefits

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.

Available Solutions

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.  The initiative previously developed sponsor and clinical trial site guidance focused on six key areas to help enhance practices and processes for diverse patient participation. The materials are available on our Initiative Solutions page.

Similar 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.