Mishra Shiva Raj, Tan Aidan C, Waller Karen, Lindley Richard I, Webster Angela C
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia; Westmead Applied Research Centre, The University of Sydney, Sydney, Australia.
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.
J Clin Epidemiol. 2025 Mar;179:111649. doi: 10.1016/j.jclinepi.2024.111649. Epub 2024 Dec 20.
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.
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.
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.
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.
公平、多样性和包容性（EDI）是社会概念，在临床试验或更广泛的临床研究中使用时，有助于为最有可能受益的人群中的干预措施生成最高质量的证据。然而，这些概念的纳入情况尚不清楚且不一致。本范围综述旨在了解EDI如何应用于临床试验以及在更广泛的临床研究中的应用情况。
我们检索了PubMed和谷歌学术上的文献，选择了1）2000年至2023年发表的研究，2）描述概念、工具、指标或框架的文献，以及3）提供有关概念化、操作化（测量）或利用（分析）信息的文献。此外，还进行了互联网搜索，以识别研究伙伴的网站，如整个研究生命周期中的政府机构、资助者、监管机构和出版商。检索到的网站被纳入我们对EDI考虑因素（概念或声明）的综述，这些因素虽未在已发表文献中出现，但对其产生影响。
我们审查了2385个标题和摘要，其中75个（3%）被纳入分析。通过对269个已识别的关键研究伙伴的灰色文献搜索，又纳入了49条记录。研究将EDI概念化为相互关联而非截然不同的结构。这些概念通常相互强化，例如增强多样性也有助于促进公平和包容的努力。在操作化方面，确定了12个框架、20种工具/指标用于整个研究生命周期的EDI评估。这些指标主要用于报告EDI数据，在整个研究生命周期中的利用仍然有限。在研究伙伴中，三分之一的出版商（20家中的6家）有任何EDI考虑；其次是19个试验注册机构中的2个，44个研究资助者中的12个，60种期刊中的7个，而伦理委员会和数据存储库均未报告有关EDI的声明。
本综述强调了一系列与EDI相关的工具、框架和指标，每个都有其独特的优势和局限性。我们发现研究伙伴对EDI考虑因素的采用仍然不足。未来的研究可以探索不同EDI标准对试验结果的影响以及试验结果的可推广性。
