Work

Existing research guidelines for inclusive trials methodology. Working toward the integration of qualitative research, equity, diversity, and inclusion and trials methodology: a focused mapping review

Year: 2026

Type: article

Abstract: Background Equity, diversity, and inclusion (EDI) are increasingly emphasised in clinical research, yet practical guidance for applying inclusion principles across all clinical trial stages remain limited. Qualitative research can help address this gap by exploring participant experiences and identifying barriers to inclusive trial conduct. Objective The aim of this review is to map guidelines and recommendations in relation to inclusive trial methodology, and to identify areas across these resources that can be potentially informed by qualitative research. This review presents Phases 1 and 2 of the QuAlitative reSearch Supporting IncluSive Trials (Q-ASSIST) Study. Methods In Phase 1, we conducted a Focused Mapping Review and Synthesis (FMRS) of publicly available guidelines related to phase 3 and later clinical trials involving human participants. Eligible guidelines included those offering recommendations to enhance inclusive trial design and conduct. Each guideline was mapped to a priori data extraction framework informed by the SPIRIT and CONSORT 2025 guidelines. We then performed a narrative synthesis to examine the EDI focus of the selected guidelines and structured the findings according to the PRO-EDI Framework. In Phase 2, we juxtaposed the trial stages identified through our FMRS with O’Cathain et al.’s Framework of Qualitative Research in Trials. Results We identified 15 guidelines through FMRS. Through conceptual mapping to SPIRIT and CONSORT headings, we developed a 12-stage trial lifecycle framework (the Q-ASSIST Trial Stages Model) to organise inclusion guidance. Most guidelines emphasised early stages of trials, with later stages less frequently addressed. Mapping to the PRO-EDI framework showed strong attention to race/ethnicity, gender, socioeconomic status, and disability, but limited focus on sexual identity, education, or intersectionality. Juxtaposition with O’Cathain et al.’s Framework highlighted similar gaps in how qualitative research has been used, especially in later trial stages. Conclusion Current inclusion guidance is concentrated in the early stages of trial design, with limited attention to later trial stages. Qualitative research offers a valuable way to address these gaps by capturing participant perspectives and supporting inclusive practices across the trial lifecycle. This review provides a foundation for developing practical tools to guide more inclusive trials, with the next phase involving co-production of guiding principles with interest holders. Plain Language Summary Including people from different backgrounds in clinical trials is important to make sure that the results apply to everyone and not just a few groups. While many organisations have developed guidelines to help researchers make clinical trials more inclusive, most of these focus on the early stages of a trial, like deciding who can take part or how to recruit participants. We wanted to understand what guidance exists for supporting inclusion throughout the entire trial process. This paper is part of the Q-ASSIST Study (QuAlitative reSearch Supporting IncluSive Trials), which explores how qualitative methods can support inclusivity across all stages of a clinical trial. Qualitative research focuses on people’s experiences, views, and the context in which research happens. It can also help identify barriers to inclusion and ways to make trials more accessible and relevant. We examined 15 publicly available guidelines designed to improve inclusion in clinical trials. We organised their recommendations according to 12 key stages of a trial, based on well-known reporting frameworks. We found that most guidelines focus on the early stages of a trial, while later stages, such as training, oversight, and what happens after the trial ends, are often overlooked We then compared our findings to an existing framework (O’Cathain et al., 2013) that shows how qualitative research has been used in trials. This comparison helped us identify specific areas where both inclusion guidance and use of qualitative research are limited. This work lays the foundation for the next phase of our study, where we will work with interest holders to develop practical tools and guiding principles that help researchers use qualitative methods to design and run more inclusive trials. By addressing these gaps, we aim to help ensure that clinical trials better represent and serve all communities, ultimately leading to treatments that work effectively for everyone.

Source: Journal of Clinical Epidemiology

DOI: 10.1016/j.jclinepi.2026.112202