Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results
Open accessAbstract
An-Wen Chan discusses the implications of a new study inPLoS Medicine that suggests that the randomized trial literature is skewed towards reporting favorable results.
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Protocols and statistical analysis plans play a central role in enhancing the transparency, reproducibility, and interpretation of trial results.
“Given the central role of protocols and statistical analysis plans in enhancing the transparency, reproducibility, and interpretation of trial results, there is a strong ethical and scientific rationale for these key documents to be publicly available.74 75 76 77 78”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [74]
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References 35 · Cited by 144
Research works printed but not linked: 2
- Chan A-W Tetzlaff J Altman DG Gøtzsche PC Hróbjartsson A 2008 The SPIRIT initiative: Defining Standard Protocol Items for Randomized Trials [conference abstract] German J Evid Quality Health Care (suppl) 102 S27
- PLoS Medicine 2008 Guidelines for authors Available: http://journals.plos.org/plosmedicine/guidelines.php#supporting. Accessed 20 October 2008
- Authors
- Chan, A.-W.
- Affiliations
- Mayo Clinic (US)
- Corresponding author
- Chan, An-Wen
- ORCID
- Chan, An-Wen
- Venue
- PLoS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2008-11-25
- Volume
- 5
- Issue
- 11
- Pages
- e230
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC2586359
- OpenAlex
- W1988851494
- Cited by
- 144
- References
- 35
- Citations by year
- 2025: 2 · 2024: 2 · 2023: 3 · 2022: 6 · 2021: 1 · 2020: 4 · 2019: 3 · 2018: 8 · 2017: 14 · 2016: 7 · 2015: 7 · 2014: 10 · 2013: 22 · 2012: 17
- FWCI
- 14.37
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- publication bias, selective reporting, research integrity
- MeSH terms
- Humans, United States, United States Food and Drug Administration, Bias, Randomized Controlled Trials as Topic, Drug Approval, Publication Bias, Mandatory Reporting
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