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

Background
Equity, diversity, and inclusion (EDI) are increasingly emphasized 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. The aim of this review is to map guidelines and recommendations in relation to inclusive trials 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 Standard Protocol Items: Recommendations for Interventional Trials and Consolidated Standards of Reporting Trials 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 Standard Protocol Items: Recommendations for Interventional Trials and Consolidated Standards of Reporting Trials headings, we developed a 12-stage trial lifecycle framework (the Q-ASSIST trial stages model) to organize inclusion guidance. Most guidelines emphasized 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 coproduction of guiding principles with interest holders.