Sample size re‐estimation in clinical trials
Abstract
Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid‐stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re‐estimation when the outcome is continuous.
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When uncertainty about a sample size estimate is acknowledged, there are methods to re-estimate sample size.
“When uncertainty about a sample size estimate is acknowledged, there are methods to re-estimate sample size.296”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [296]
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References 25 · Cited by 132
- Authors
- Proschan, M. A.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- Proschan, Michael A.
- ORCID
- Proschan, Michael A.
- Venue
- Biometrical Journal
- Publisher
- Wiley
- Published
- 2009-04
- Volume
- 51
- Issue
- 2
- Pages
- 348-357
- ISSN
- 0323-3847 (ISSN-L)
- 1521-4036
- OpenAlex
- W2078021680
- Cited by
- 132
- References
- 25
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 6 · 2023: 6 · 2022: 9 · 2021: 5 · 2020: 10 · 2019: 10 · 2018: 6 · 2017: 4 · 2016: 4 · 2015: 7 · 2014: 4 · 2013: 8 · 2012: 13
- FWCI
- 8.85
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biometrical Journal (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
- Physical Sciences › Mathematics › Statistics and Probability › Probability and Statistical Research
- Keywords
- sample size re-estimation, adaptive clinical trials, continuous outcomes, clinical trial design
- MeSH terms
- Clinical Trials as Topic, Computer Simulation, Models, Statistical, Sample Size, Patient Selection
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