Underrepresentation of racial minorities, ethnic minorities, and women in U.S. clinical trials limits knowledge of investigational medical products’ (IMPs) safety and efficacy, reducing the availability of evidence-based treatment guidelines for underrepresented populations. Despite ample scientific evidence of treatment response differences in underrepresented populations and numerous initiatives to increase diversity in clinical trials, systemic change remains elusive—presenting the clinical trial ecosystem with a serious human subject protection issue and a broader public health threat.

Over time, awareness and support for patient centricity in clinical trials has increased. However, commitment to creating targeted, scientifically driven strategies to increase the participation of underrepresented patient populations in clinical trials remains insufficient. Gaps in knowledge about the value and impact of initiatives to increase diversity in clinical trials weakens resolve to allocate necessary resources to the development of clinical trial infrastructures that address the needs of diverse patient populations.

CTTI’s project aims to address this gap through generating resources that demonstrate the value of increasing diverse patient populations’ participation in the development of drugs and devices—from initial target identification to clinical trial conduct.

• Increasing Diversity in Clinical Trials

• Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
• Identify incentives & disincentives for decision makers to invest sufficient resources in
  organizational-level practices that increase diversity in clinical trials.
• Identify factors that yield clinical, scientific, and financial return on investment from
  engaging diverse populations in clinical trials.

Greater inclusion of diverse patient populations in clinical trials.

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.