Data fraud in clinical trials.
Open accessAbstract
Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality.
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Flagging trials where the baseline table is under-dispersed might protect journals from publishing fraudulent papers, as this has been a clue in previous fraud investigations.
“Flagging trials where the baseline table is under-dispersed might protect journals from publishing fraudulent papers, as this has been a clue in previous fraud investigations. 35”
From Automated detection of over- and under-dispersion in baseline tables in randomised controlled trials. (2022) · cites this paper as [35]
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References 75 · Cited by 126
Research works printed but not linked: 1
- [1]Institute of Medicine, National Academy of Sciences, National Academy of Engineering On Being a Scientist: A Guide to Responsible Conduct in Research 3 The National Academies Press Washington, DC, USA 2009 25009901
- Authors
- George, S. L., & Buyse, M.
- Affiliations
- Duke University (US)
- Venue
- Clinical Investigation
- Publisher
- OMICS Publishing Group
- Published
- 2015-02
- Volume
- 5
- Issue
- 2
- Pages
- 161-173
- ISSN
- 2041-6792 (ISSN-L)
- 2041-6806
- PMC
- PMC4340084
- OpenAlex
- W2167976345
- Cited by
- 126
- References
- 75
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 8 · 2023: 8 · 2022: 17 · 2021: 21 · 2020: 13 · 2019: 14 · 2018: 10 · 2017: 9 · 2016: 2 · 2015: 7
- FWCI
- 27.14
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Investigation (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P01CA142538)
- Topics
- Social Sciences › Safety Research › Academic integrity and plagiarism
- Physical Sciences › Mathematics › Statistics and Probability › Benford’s Law and Fraud Detection
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- data fraud, clinical trials, research misconduct, data fabrication, data falsification, fraud detection, data quality, clinical trial monitoring, fraud motivation
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