Authors' reports about research integrity problems in clinical trials
Abstract
Background There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research. Methods We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about. Results We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct. Conclusions Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct.
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One survey found that 29% of the cases of misconduct known by respondents were never discovered.
“One survey [27] found that 29% of the cases of misconduct known by respondents were never discovered.”
From How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data (2009) · cites this paper as [27]
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- Authors
- Gardner, W., Lidz, C. W., & Hartwig, K. C.
- Affiliations
- The Ohio State University (US)
- University of Massachusetts Chan Medical School (US)
- University of Pittsburgh (US)
- Corresponding author
- Gardner, William
- ORCID
- Gardner, William
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2005-04
- Volume
- 26
- Issue
- 2
- Pages
- 244-251
- ISSN
- 1551-7144 (ISSN-L)
- OpenAlex
- W2022942552
- Cited by
- 69
- References
- 18
- Citations by year
- 2025: 1 · 2024: 4 · 2023: 5 · 2022: 2 · 2021: 4 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 3 · 2016: 4 · 2015: 2 · 2014: 2 · 2013: 3 · 2012: 4
- FWCI
- 17.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- The Journal of the American Medical Association (JAMA) Network (American Medical Association) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- National Institutes of Health (7r01ns042449-03)
- National Institute of Neurological Disorders and Stroke (R01 NS42449)
- Topics
- Social Sciences › Safety Research › Academic integrity and plagiarism
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Benford’s Law and Fraud Detection
- Keywords
- research integrity, research misconduct, data fabrication, pharmaceutical clinical trials, author survey, research misconduct prevention, Cochrane Database of Systematic Reviews
- MeSH terms
- Adult, Authorship, Clinical Trials as Topic, Data Collection, Drug Evaluation, Female, Humans, Male, Middle Aged, Publishing, Research Personnel, Correspondence as Topic, Scientific Misconduct, Ethics, Research
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