Problems of stopping trials early
Abstract
When interim analyses of randomised trials suggest large beneficial treatment effects, investigators sometimes terminate trials earlier than planned. Gordon H Guyatt and colleagues show how this practice can have far reaching and harmful consequences
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The trial was stopped early at a planned interim analysis, which may have limited the power for some secondary outcomes and may increase the risk of overestimating effect sizes.
“First, the trial was stopped early at a planned interim analysis, which may have limited the power for some secondary outcomes and may increase the risk of overestimating effect sizes.21”
From Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (2019) · cites this paper as [21]
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- Authors
- Guyatt, G. H., Briel, M., Glasziou, P., Bassler, D., & Montori, V. M.
- Affiliations
- McMaster University (CA)
- University Hospital of Basel (CH)
- Bond University (AU)
- University Children's Hospital Tübingen (DE)
- Mayo Clinic (US)
- Corresponding author
- Guyatt, G. H.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2012-06-15
- Volume
- 344
- Issue
- jun15 1
- Pages
- e3863-e3863
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W1995995252
- Cited by
- 115
- References
- 17
- Citations by year
- 2025: 3 · 2024: 8 · 2023: 11 · 2022: 8 · 2021: 7 · 2020: 11 · 2019: 15 · 2018: 6 · 2017: 12 · 2016: 7 · 2015: 8 · 2014: 11 · 2013: 7
- FWCI
- 7.94
- Type
- journal article
- Language
- en
- Update notices
- correction (2014-01-21)
- Open access
- closed
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- Bond University Research Portal (Bond University) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- early trial termination, interim analysis, randomized controlled trials, treatment effect estimation, statistical power
- MeSH terms
- Adrenergic beta-Antagonists, Decision Making, Humans, Insulin, Myocardial Infarction, Protein C, Research Design, Surgical Procedures, Operative, Time Factors, Randomized Controlled Trials as Topic, Critical Illness, Treatment Outcome, Sepsis, Endpoint Determination, Clinical Trials Data Monitoring Committees, Ethics, Research
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