The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Statistical Problems in the Reporting of Clinical Trials
Abstract
Reports of clinical trials often contain a wealth of data comparing treatments. This can lead to problems in interpretation, particularly when significance testing is used extensively. We examined 45 reports of comparative trials published in the British Medical Journal, the Lancet, or the New England Journal of Medicine to illustrate these statistical problems. The issues we considered included the analysis of multiple end points, the analysis of repeated measurements over time, subgroup analyses, trials of multiple treatments, and the overall number of significance tests in a trial report. Interpretation of large amounts of data is complicated by the common failure to specify in advance the intended size of a trial or statistical stopping rules for interim analyses. In addition, summaries or abstracts of trials tend to emphasize the more statistically significant end points. Overall, the reporting of clinical trials appears to be biased toward an exaggeration of treatment differences. Trials should have a clearer predefined policy for data analysis and reporting. In particular, a limited number of primary treatment comparisons should be specified in advance. The overuse of arbitrary significance levels (for example, P less than 0.05) is detrimental to good scientific reporting, and more emphasis should be given to the magnitude of treatment differences and to estimation methods such as confidence intervals.
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A method for assessing the quality of a randomized control trial
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Cited by
Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing
Benjamini, Y., & Hochberg, Y. (1995) · Journal of the Royal Statistical Society Series B: Statistical Methodology · doi:10.1111/j.2517-6161.1995.tb02031.x · Cited by 109,482
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000100 · Cited by 28,164
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gotzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · BMJ · doi:10.1136/bmj.b2700 · Cited by 17,648
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Metadata
- Authors
- Pocock, S. J., Hughes, M. D., & Lee, R. J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1987-08-13
- Volume
- 317
- Issue
- 7
- Pages
- 426-432
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1977833499
- Cited by
- 662
- References
- 1
- FWCI
- 33.13
- Type
- journal article
- Language
- en
- Open access
- closed
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
