Conceptualizing, operationalizing, and utilizing equity, diversity, and inclusion in clinical trials: a scoping review

Abstract

OBJECTIVES: Equity, diversity, and inclusion (EDI) are social constructs which when used in clinical trials, or clinical research broadly help generate the highest quality evidence for interventions in the populations most likely to benefit. However, the incorporation of these constructs is unclear and inconsistent. This scoping review sought to understand how EDI is applied in clinical trials with broader application across clinical research. METHODS: We reviewed literature from PubMed and Google Scholar, selecting studies 1) published from 2000 to 2023, 2) literature which described concepts, tools, metrics, or frameworks, and 3) provided information on conceptualization, operationalization (measuring) or utilization (analyzing). Additionally, internet searches were conducted to identify websites of research partners such as government institutions, funders, regulators and publishers across the research lifecycle. Websites retrieved were included for our review of EDI consideration (either concepts or statements) outside but impacting upon the published literature. RESULTS: We reviewed 2385 titles and abstracts and included 75 (3%) in analyses. From gray literature searches of 269 identified key research partners, additional 49 records were included. Studies conceptualized EDI as interconnected rather than distinct constructs. These concepts were often reinforcing, such as efforts to enhance diversity which also promote equity and foster inclusion. Regarding operationalization, 12 frameworks, 20 tools/metrics were identified for EDI assessment across the research lifecycle. These metrics were primarily used for reporting EDI data, and utilization across research lifecycle remains limited. Among research partners, a third of publishers (6 of 20) had any EDI considerations; followed by 2 of 19 trial registries, 12 of 44 research funders, 7 of 60 journals, and none of ethics committee and data repositories reported statements on EDI. CONCLUSIONS: This review highlights that a range of EDI relevant tools, frameworks and metrics, each with their unique strengths and limitations. We found a wider adoption of EDI considerations by research partners is still lacking. Future research could explore the impact of different EDI criteria on trial outcomes and the generalizability of trial results.