Statistics Applied to Clinical Trials by Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas

By Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas (auth.)

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Federal Register, 63 (179), 1998: 49583-49598. 3. Food and Drug Administration. Guideline for Industry. Structure and Content of Clinical Study reports. HTMIGUIDANCE DOCUMENTS. 4. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika, 1977,64: 191-199. 5. Demets DL, Ware JH. Group sequential methods in clinical trials with a one-sided hypothesis. Biometrika, 1980, 67: 651-660. 6. Wald A. Sequential Analysis. New York: Wiley, 1947. 7. Annitage P. Sequential Medical Trials.

The steering committee should be infonned about the decisions to continue or discontinue or the implementation of protocol amendments only. VIII - There is little advantage to be gained from carrying out a large number of interim analyses: the consequences of executing many interim analyses are that the sample sizes are small (at least in the first analyses), and that a smaller significance level must be used. Pocock! (page 153) recommends never to plan more than 5 interim analyses, but at the same time to plan at least one interim analysis, in order to warrant scientific and ethical validity of the trial.

A different theory would tell you that the more intensive the therapy the better the result. This latter theory was recently tested in the HOT trial! (HOT investigators, Lancet 1998; 87: 133), but could not be confirmed: high dosage antihypertensive therapy was not significantly better than mediumdosage therapy. Probably it was not worse either, however, unfortunately, this was not tested in the report. The study would definitely have been powerful to test this question, and, moreover, it would have solved a major so far unsolved discussion.

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