Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone

Abstract

Healthcare disparities are a persistent societal problem. One of the contributing factors to this status quo is the lack of diversity and representativeness of research efforts, which result in nongeneralizable evidence that, in turn, provides suboptimal means to enable the best possible outcomes at the individual level. There are several strategies that research teams can adopt to improve the diversity, equity, and inclusion (DEI) of their efforts; these strategies span the totality of the research path, from initial design to the shepherding of clinical data through a potential regulatory process. These strategies include more intentionality and DEI‐based goal‐setting, more diverse research and leadership teams, better community engagement to set study goals and approaches, better tailored outreach interventions, decentralization of study procedures and incorporation of innovative technology for more flexible data collection, and self‐surveillance to identify and prevent biases. Within their remit of overlooking research efforts, regulatory authorities, as stakeholders, also have the potential for a positive effect on the DEI of emerging clinical evidence. All these are implementable tools and mechanisms that can make study participation more approachable to diverse communities, and ultimately generate evidence that is more generalizable and a conduit for better outcomes. The research community has an imperative to make DEI principles key foundational aspects in study conduct in order to pursue better personalized medicine for diverse patient populations.

An Equity and Justice-Informed Ethical Framework to Guide Incidental Findings in Brain Imaging Research

“…Overall, the principles of DEI can be applied to the field of human research ethics in order to ensure that research is conducted in a fair and just manner and that the benefits of research are shared equitably among all members of society. By applying DEI principles to human research, we can help to create a more diverse, equitable, and inclusive society [ 38 ].…”

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.…”

“…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. Of note, some of the identified strategies, like decentralization and technology-driven flexibility in data collection, are notable opportunities to leverage quantitative clinical pharmacology methods for design optimization and analysis applying principles of model-informed drug development.…”

“…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.…”

Leveraging the Academic Artificial Intelligence Silecosystem to Advance the Community Oncology Enterprise

“…Novel initiatives aim to improve and maintain broad population representation within health care data sets and across AI platforms. These initiatives include the implementation of intentionally diverse data sets [141], the enactment of more effective legislative guidelines to promote equity and diversity [142] and initiation of proactive community programs to promote health research participation [143].…”