The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
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
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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“For this reason, considering limited resources and budget, sample size calculation and power analysis may require a trade-off between cost-effectiveness and power [3,4].”
From Sample size determination and power analysis using the G*Power software (2021) · cites this paper as [4]
Citations
Cites
Statistical methods for rates and proportions
Fleiss, J., Levin, B., & Paik, M. (1973) · Biometrics · doi:10.2307/2529186 · Cited by 21,632
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
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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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Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
The Handbook of Research Synthesis and Meta-Analysis
(2019) · doi:10.7758/9781610448864 · Cited by 4,553
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement
Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127
Metadata
- 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
- 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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