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Reporting summary results in clinical trial registries: updated guidance from WHO
Open accessAbstract
The importance of publicly registering clinical trials and reporting their results in registries is widely recognised. While substantial progress has been made with registering trials before enrolment, the availability of results in registries remains uncommon despite expanding legislative and funder requirements-leading to an incomplete evidence base and avoidable waste of resources, particularly for unpublished trials. This paper discusses the rationale for reporting summary results in trial registries, reviews the current landscape of registry policies, and presents new WHO guidance for reporting results in registries. The 2025 WHO guidance was developed after consultation with relevant parties, including researchers, patients, sponsors, funders, regulators, journal editors, registry administrators, and the public. The guidance defines eight minimum items that are essential for understanding and interpreting the summary results for all trials. Implementation of the WHO guidance by trial registries, broad adherence by investigators and sponsors, and endorsement by funders, regulators, legislators, research ethics committees, patient organisations, and journals can help enhance the contribution of trials to scientific knowledge, patient care, and health policy.
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SPIRIT 2025 has been designed to complement and enhance the expanding trial registration requirements mandated by legislation, journals, and funding policies.
“SPIRIT 2025 has been designed to complement and enhance the expanding trial registration requirements mandated by legislation, journals, and funding policies.35”
From SPIRIT 2025 statement: updated guideline for protocols of randomised trials (2025) · cites this paper as [35]
Beyond journal publication, trial registries and preprint servers are important venues for dissemination.
“Beyond journal publication, trial registries and preprint servers are important venues for dissemination.121 122 123”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [123]
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References 65 · Cited by 24
Metadata
- Authors
- Chan, A.-W., Karam, G., Pymento, J., Askie, L. M., da Silva, L. R., Aymé, S., Taylor, C. M., Hooft, L., Ross, A. L., & Moorthy, V.
- Affiliations
- University of Toronto (CA)
- World Health Organization (CH)
- Inserm (FR)
- University Medical Center Utrecht (NL)
- Corresponding author
- Chan, An-Wen
- ORCID
- Venue
- The Lancet Global Health
- Publisher
- Elsevier BV
- Published
- 2025-04
- Volume
- 13
- Issue
- 4
- Pages
- e759-e768
- ISSN
- 2214-109X (ISSN-L)
- OpenAlex
- W4408936335
- Cited by
- 24
- References
- 65
- Citations by year
- 2026: 12 · 2025: 12
- FWCI
- 4.58
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- The Lancet Global Health (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Funders
- World Health Organization
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Social Sciences › Library and Information Sciences › Academic Publishing and Open Access
- Keywords
- clinical trial registries, WHO guidelines, clinical trial registration, unpublished trials, research transparency
- MeSH terms
- Clinical Trials as Topic, Humans, Registries, World Health Organization, Guidelines as Topic
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