Enhancing Diversity and Inclusion in Clinical Trials

Abstract

Women and people from most racial and ethnic groups in the United States have historically been under‐represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study‐level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational‐level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas—commitment, partnerships, accountability, and resources—on sustaining organizational‐level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational‐level approaches to improve equitable access and diverse patient participation in clinical trials.

Assessing Ethnic Minority Representation in Fibromyalgia Clinical Trials: A Systematic Review of Recruitment Demographics

“…Despite these recent initiatives, such efforts and more should apply to all research designs globally. However, testing treatments across all populations at each clinical trial stage in drug development is very challenging, and would require major infrastructure and funding regulations, due to the majority of research being based in Western countries [90,91,98]. More collaborative efforts similar to this could be made with researchers in other countries, i.e., drugs that fail at earlier stages in White cohorts could be tested in groups of participants in Asia, Latin America, and Africa, in order to test their possible differential efficacies.…”

Integrating Diversity, Equity, and Inclusion into Preclinical, Clinical, and Public Health Mathematical Models

“…By considering diversity in various facets—from biobanks to cells to organoid systems (Co et al 2023 ) to animals—preclinical mathematical models can be used to improve the success of candidate molecules and increase the successful transition into clinical trials. Historically, clinical trials, especially early-phase, have been run in a homogenous group of individuals (Merkatz 1998 ) (typically younger, Caucasian men) without the integration of gender, racial, ethnic, age, and other forms of diversity (Corneli et al 2023 ). Increasing awareness of this reality has intensified calls for greater inclusions of human diversity within trials (Corneli et al 2023 ; Washington et al 2022 ).…”

Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All

“…Mohan and Freedman 24 review three exemplary clinical trials in diverse therapeutic areas—coronavirus disease 2019 (COVID‐19), multiple sclerosis, and diabetic macular edema—where an emphasis on inclusion or exclusive enrollment of historically underrepresented racial and ethnic groups was a key focus of design and operationalization. The authors discuss community engagement, site selection strategy, patient‐centered approaches to communication, and breaking barriers to participation as key enablers, in resonance with several of the recommendations offered through insights from CTTI's qualitative research, 22 the roadmap presented by Washington et al ., 23 and MacLennan et al . 's 25 survey of site‐level clinical research professionals.…”

“…As articulated by the authors, the purpose is simple-ensuring that the clinical trial population reflects the diversity of patients likely to take a medical product if it is approved. In their White Paper outlining the findings from qualitative research by the Clinical Trials Transformation Initiative (CTTI) Diversity Team, Corneli and colleagues 22 present the insights gained from interviews with leaders at institutions that conduct clinical trials that were designed to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Washington et al 23 review facilitators for actionable enhancement of diversity, equity, and inclusion (DEI) at all stages of clinical development-planning/design, protocol generation, accrual/enrollment, study conduct, analysis of results, and evidence generation for regulatory review.…”

“…Mohan and Freedman 24 review three exemplary clinical trials in diverse therapeutic areas-coronavirus disease 2019 (COVID-19), multiple sclerosis, and diabetic macular edema-where an emphasis on inclusion or exclusive enrollment of historically underrepresented racial and ethnic groups was a key focus of design and operationalization. The authors discuss community engagement, site selection strategy, patient-centered approaches to communication, and breaking barriers to participation as key enablers, in resonance with several of the recommendations offered through insights from CTTI's qualitative research, 22 the roadmap presented by Washington et al, 23 As articulated by Brown et al 28 in their Call to Action contributed by a diverse group of members of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) working across sectors of practice and scientific disciplines, prioritization of DEI across all facets of our work should be a priority for the clinical pharmacology community. This applies not only to increasing diversity in clinical research, but further for broadening the diversity in our workforce-nurturing authenticity, empathy, and continuous evolution-with benefits ranging from better business performance to improved decision making.…”