Equitable inclusion of people with disabilities in clinical trials: a scoping review

OBJECTIVES: People with disabilities are underrepresented in clinical trials, which impacts generalisability and ethical integrity of results. Despite international mandates to diversify participants, there is a lack of guidance on how to make trials disability-inclusive. This scoping review identifies and synthesises guidance, practices and recommendations supporting the inclusion of people with disabilities in clinical trials. DESIGN: We conducted a scoping review following the Arksey and O'Malley framework and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for scoping reviews. DATA SOURCES: Medline (OVID) and Public Affairs Information System Index (October 2024) searches identified peer-reviewed articles. Grey literature was identified through targeted advanced Google searches and website reviews (February-March 2025). Google Scholar was searched to identify recently published documents between March and April 2025. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Documents with guidance or policies related to inclusion of people with disabilities in clinical trials published in English from 2019 to 2025 were included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers screened titles, abstracts and full texts and extracted data, with adjudication by a third reviewer. RESULTS: A total of 69 documents met inclusion criteria. Thematic synthesis identified eight recommendation domains: (1) inclusive and universal trial design, (2) accessible recruitment, (3) inclusive data collection, (4) equitable data analysis, (5) accessible reporting and dissemination, (6) ethical oversight and institutional review board inclusion, (7) supported and accessible consent processes and (8) the inclusion of people with disabilities as researchers and stakeholders. Themes cutting across all domains included guidance emphasising universal design, anti-ableist frameworks, supported decision-making, flexible protocols and engagement with disability communities. CONCLUSION: Disability-inclusive clinical trials are essential to ensure the validity of clinical trial results, uphold ethical responsibilities and advance health equity. While emerging frameworks offer direction on how to include people with disabilities in trials, current implementation remains inconsistent and largely voluntary. Clear, enforceable standards are needed to support governments, ethics boards, institutions and funders in making clinical trials more disability-inclusive.