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.

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.

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.

Documents with guidance or policies related to inclusion of people with disabilities in clinical trials published in English from 2019 to 2025 were included.

Two independent reviewers screened titles, abstracts and full texts and extracted data, with adjudication by a third reviewer.

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.

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.

Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.

The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.

The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.