Evidence map›Paper›PMID 41638736›Full record

ArticleBMJ open2026

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

Grace Jo, Franz Castro, Caroline Cerilli, Varshini Varadaraj, Lori Rosman, Kaloyan Kamenov, Darryl Barrett, Bonnielin Swenor

Abstract readScoping Review
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Grace JoDisability Health Research Center, Johns Hopkins University, Baltimore, Maryland, USA.ORCID http://orcid.org/0009-0007-8260-6733
Franz CastroDisability Health Research Center, Johns Hopkins University, Baltimore, Maryland, USA.
Caroline CerilliDisability Health Research Center, Johns Hopkins University, Baltimore, Maryland, USA.
Varshini VaradarajDisability Health Research Center, Johns Hopkins University, Baltimore, Maryland, USA.
Lori RosmanWelch Medical Library, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kaloyan KamenovDisability Programme, World Health Organization, Geneva, Switzerland.ORCID http://orcid.org/0000-0002-4355-6186
Darryl BarrettDisability Programme, World Health Organization, Geneva, Switzerland.
Bonnielin SwenorDisability Health Research Center, Johns Hopkins University, Baltimore, Maryland, USA bswenor@jhmi.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPeople 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.

designWe 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.

resultsA 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.

conclusionDisability-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.

Indexed as

Clinical Trials as TopicPatient SelectionPersons with DisabilitiesDiversity, Equity, InclusionHumansClinical TrialHealth policyPUBLIC HEALTH

Identifiers

PMID41638736
PMCPMC12878309

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.