Conceptualising, operationalising and utilising equity, diversity and inclusion in clinical trials: a scoping review.

Introduction: Equity, diversity and inclusion (EDI) are social constructs which when used in clinical trials help generate the highest quality evidence for interventions in the populations most likely to benefit. However, the incorporation of these constructs in clinical trials is unclear and inconsistent. This scoping review sought to understand how EDI is applied in clinical trials.

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 around EDI applied to clinical trials, and 3) providing information on conceptualisation (definition), operationalisation (measuring) or utilisation (analysing). 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 definitions or statements) outside but impacting upon the published literature.

Results: We reviewed 2385 titles and abstracts and included 75 (3%) in analyses. From grey literature searches of 269 identified key research partners, an additional 49 records were included. Studies conceptualised 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 operationalisation, 12 frameworks, 20 tools/metrics were identified for EDI assessment across the research lifecycle. These metrics were primarily used for reporting EDI data, and utilisation across research lifecycle remains limited. Among research partners, a third of publishers (6/20) had any EDI considerations; followed by 2/19 trial registries, 12/44 research funders, 7/60 journals, and none of ethics committee and data repositories reported statements on EDI.

Conclusions: This review highlights that a range of tools, frameworks and metrics are used in clinical trials, 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 generalisability of trial results.