The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Statistical Principles for Clinical Trials
Abstract
If a trial is to be well designed, and the conclusions drawn from it valid, a thorough understanding of the benefits and pitfalls of basic statistical principles is required. When setting up a trial, appropriate sample-size calculation is vital. If initial calculations are inaccurate, trial results will be unreliable. The principle of intent-to-treat in comparative trials is examined. Randomization as a method of selecting patients to treatment is essential to ensure that the treatment groups are equalized in terms of avoiding biased allocation in the mix of patients within groups. Once trial results are available the correct calculation and interpretation of the P-value is important. Its limitations are examined, and the use of the confidence interval to help draw valid conclusions regarding the clinical value of treatments is explored.
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Citations
Cites
Confidence intervals rather than P values: estimation rather than hypothesis testing.
Gardner, M. J., & Altman, D. G. (1986) · BMJ · doi:10.1136/bmj.292.6522.746 · Cited by 2,010
The Coronary Drug Project Research Group (1980) · New England Journal of Medicine · doi:10.1056/nejm198010303031804 · Cited by 659
Statistical Tables for the Design of Clinical Trials.
Wickham, C. A. C., Machin, D., & Campbell, M. J. (1988) · Journal of the Royal Statistical Society. Series A (Statistics in Society) · doi:10.2307/2982784 · Cited by 426
Cited by
Mitsudomi, T., Morita, S., Yatabe, Y., Negoro, S., Okamoto, I., Tsurutani, J., Seto, T., Satouchi, M., Tada, H., Hirashima, T., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70364-x · Cited by 4,090
Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., Altman, D. G., & CONSORT Group, F. T. (2012) · JAMA · doi:10.1001/jama.2012.87802 · Cited by 2,428
Phases of Biomarker Development for Early Detection of Cancer
Pepe, M. S., Etzioni, R., Feng, Z., Potter, J. D., Thompson, M. L., Thornquist, M., Winget, M., & Yasui, Y. (2001) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/93.14.1054 · Cited by 1,686
Jacobsen, L., Niggemann, B., Dreborg, S., Ferdousi, H. A., Halken, S., Høst, A., Koivikko, A., Norberg, L. A., Valovirta, E., Wahn, U., et al. (2007) · Allergy · doi:10.1111/j.1398-9995.2007.01451.x · Cited by 976
A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
Thabane, L., Mbuagbaw, L., Zhang, S., Samaan, Z., Marcucci, M., Ye, C., Thabane, M., Giangregorio, L., Dennis, B., Kosa, D., et al. (2013) · BMC Medical Research Methodology · doi:10.1186/1471-2288-13-92 · Cited by 893
Metadata
- Authors
- Kay, R.
- Venue
- Journal of International Medical Research
- Publisher
- SAGE Publications
- Published
- 1998-03
- Volume
- 26
- Issue
- 2
- Pages
- 57-65
- ISSN
- 0300-0605 (ISSN-L)
- 1473-2300
- OpenAlex
- W1958971206
- Cited by
- 573
- References
- 3
- FWCI
- 15.77
- Type
- journal article
- Language
- en
- Open access
- closed
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- Kay, R. (1998). Statistical Principles for Clinical Trials. Journal of International Medical Research. https://doi.org/10.1177/030006059802600201
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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