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British Medical Journal (Clinical Research Ed.) logoLink to British Medical Journal (Clinical Research Ed.)
. 1985 Jan 5;290(6461):39–42. doi: 10.1136/bmj.290.6461.39

Current issues in the design and interpretation of clinical trials.

S J Pocock
PMCID: PMC1415390  PMID: 3917328

Abstract

Though there have been considerable improvements in the use of statistical methods for clinical trials in recent years, there remain major practical difficulties in the design and interpretation of many trials. This paper concentrates on problems relating to randomisation, the overemphasis on significance testing, and the inadequate size of many trials. Each topic is illustrated by examples from recent trials.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Epstein O., Jain S., Lee R. G., Cook D. G., Boss A. M., Scheuer P. J., Sherlock S. D-penicillamine treatment improves survival in primary biliary cirrhosis. Lancet. 1981 Jun 13;1(8233):1275–1277. doi: 10.1016/s0140-6736(81)92456-9. [DOI] [PubMed] [Google Scholar]
  2. Hjermann I., Velve Byre K., Holme I., Leren P. Effect of diet and smoking intervention on the incidence of coronary heart disease. Report from the Oslo Study Group of a randomised trial in healthy men. Lancet. 1981 Dec 12;2(8259):1303–1310. doi: 10.1016/s0140-6736(81)91338-6. [DOI] [PubMed] [Google Scholar]
  3. Medical Research Council Vitamin Study. Lancet. 1984 Jun 9;1(8389):1308–1308. [PubMed] [Google Scholar]
  4. 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. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976 Dec;34(6):585–612. doi: 10.1038/bjc.1976.220. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Pocock S. J., Lagakos S. W. Practical experience of randomization in cancer trials: an international survey. Br J Cancer. 1982 Sep;46(3):368–375. doi: 10.1038/bjc.1982.212. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Simon R. Restricted randomization designs in clinical trials. Biometrics. 1979 Jun;35(2):503–512. [PubMed] [Google Scholar]
  7. Smithells R. W., Sheppard S., Schorah C. J., Seller M. J., Nevin N. C., Harris R., Read A. P., Fielding D. W. Possible prevention of neural-tube defects by periconceptional vitamin supplementation. Lancet. 1980 Feb 16;1(8164):339–340. doi: 10.1016/s0140-6736(80)90886-7. [DOI] [PubMed] [Google Scholar]
  8. White S. J., Freedman L. S. Allocation of patients to treatment groups in a controlled clinical study. Br J Cancer. 1978 May;37(5):849–857. doi: 10.1038/bjc.1978.124. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Zelen M. Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors. J Clin Oncol. 1983 Feb;1(2):164–169. doi: 10.1200/JCO.1983.1.2.164. [DOI] [PubMed] [Google Scholar]

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