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
Fleiss, J., Levin, B., & Paik, M. (1973) · Biometrics · doi:10.2307/2529186 · Cited by 21,632
Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1976) · British Journal of Cancer · doi:10.1038/bjc.1976.220 · Cited by 2,294
Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation
(1948) · BMJ · doi:10.1136/bmj.2.4582.769 · Cited by 986
ABSENCE OF PROPHYLACTIC EFFECT OF PROPRANOLOL IN MYOCARDIAL INFARCTION
Clausen, J., Felsby, M., Jørgensen, F. S., NIELSEN, B. L., Róin, J., & Strange, B. (1966) · The Lancet · doi:10.1016/s0140-6736(66)90533-2 · Cited by 125
Statistics in medical research: principles versus practices.
Schoolman, H. M., Becktel, J. M., Best, W. R., & Johnson, A. F. (1968) · PubMed · Cited by 33

Show all 5 references

Research works printed but not linked: 2

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

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Pooled analyses of randomized trials of streptokinase and heparin in phlebographically documented acute deep venous thrombosis
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Bartels, R., Verhagen, W. I. M., van der Wilt, G. J., Meulstee, J., van Rossum, L. G. M., & Grotenhuis, J. A. (2005) · Neurosurgery · doi:10.1227/01.neu.0000154131.01167.03 · Cited by 285
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Bailey, W. C. (1990) · Archives of Internal Medicine · doi:10.1001/archinte.1990.00040031664013 · Cited by 281
Spinal Manipulation for Low Back Pain
Koes, B. W., Assendelft, W. J., van der Heijden, G. J. M. G., & Bouter, L. M. (1996) · Spine · doi:10.1097/00007632-199612150-00013 · Cited by 280
Prevention of calcium stones with thiazides
Yendt, E. R., & Cohanim, M. (1978) · Kidney International · doi:10.1038/ki.1978.58 · Cited by 280
Reporting of sample size calculation in randomised controlled trials: review
Charles, P., Giraudeau, B., Dechartres, A., Baron, G., & Ravaud, P. (2009) · BMJ · doi:10.1136/bmj.b1732 · Cited by 274
Macrosomy despite well-controlled diabetic pregnancy.
Russell, G., Farmer, G., Lloyd, D., Pearson, D. M., Ross, I. S., Stowers, J., Sutherland, H. W., Visser, G. H., van Ballegooie, E., Sluiter, W. J., et al. (1984) · PubMed · Cited by 274
Overview: deinstitutionalization of psychiatric patients, a critical review of outcome studies
Braun, P., Kochansky, G. E., Shapiro, R., Greenberg, S., Gudeman, J. E., Johnson, S., & Shore, M. F. (1981) · American Journal of Psychiatry · doi:10.1176/ajp.138.6.736 · Cited by 274
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Koes, B. W., Assendelft, W. J., van der Heijden, G. J. M. G., Bouter, L. M., & Knipschild, P. G. (1991) · BMJ · doi:10.1136/bmj.303.6813.1298 · Cited by 270
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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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