Cited by 1,628Statistical Methods in Clinical TrialsStatistical Methods in EpidemiologyMeta-analysis and systematic reviews

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The Importance of Beta, the Type II Error and Sample Size in the Design and Interpretation of the Randomized Control Trial: Survey of 71 Negative Trials

Freiman, Jennie A., Chalmers, Thomas C., Smith, Harry, Kuebler, Roy R.·1978·New England Journal of Medicine

DOI 10.1056/nejm197809282991304

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Abstract

Seventy-one "negative" randomized control trials were re-examined to determine if the investigators had studied large enough samples to give a high probability (greater than 0.90) of detecting a 25 per cent and 50 per cent therapeutic improvement in the response. Sixty-seven of the trials had a greater than 10 per cent risk of missing a true 25 per cent therapeutic improvement, and with the same risk, 50 of the trials could have missed a 50 per cent improvement. Estimates of 90 per cent confidence intervals for the true improvement in each trial showed that in 57 of these "negative" trials, a potential 25 per cent improvement was possible, and 34 of the trials showed a potential 50 per cent improvement. Many of the therapies labeled as "no different from control" in trials using inadequate samples have not received a fair test. Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials.

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Statistical methods for rates and proportions
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Feinstein AR: Clinical Biostatistics. St Louis, CV Mosby, 1977, pp 320–334
Schoolman, 1968, J Lab Clin Med, 71, 357

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Authors: Freiman, J. A., Chalmers, T. C., Smith, H., & Kuebler, R. R.
ORCID: Smith, Harry
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1978-09-28
Volume: 299
Issue: 13
Pages: 690-694
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm197809282991304
OpenAlex: W1970046651
Cited by: 1,628
References: 5
Citations by year: 2026: 8 · 2025: 11 · 2024: 14 · 2023: 14 · 2022: 13 · 2021: 30 · 2020: 14 · 2019: 22 · 2018: 52 · 2017: 22 · 2016: 25 · 2015: 24 · 2014: 22 · 2013: 30 · 2012: 30
FWCI: 61.86
Type: journal article
Language: en
Open access: closed
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: type II error, sample size, randomized controlled trials, negative trial results, statistical power, confidence intervals, clinical trial design, trial interpretation
MeSH terms: Clinical Trials as Topic, Humans, Probability, Research, Research Design, Therapeutics

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The Importance of Beta, the Type II Error and Sample Size in the Design and Interpretation of the Randomized Control Trial: Survey of 71 Negative Trials

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