Interim Analyses in Randomized Clinical Trials: Ramifications and Guidelines for Practitioners
- 1 March 1987
- journal article
- research article
- Published by JSTOR in Biometrics
- Vol. 43 (1) , 213-223
- https://doi.org/10.2307/2531962
Abstract
Recent developments in group sequential methods have had a great impact on the design and analysis of randomized clinical trials. The consequences for both planned and unplanned interim analyses are discussed using several real trials as illustrations. Guidelines for the conduct of interim analysis are given, including tables of nominal significance levels and required sample sizes for several group sequential plans. Areas in need of further theoretical advance include multiple endpoints, estimation of treatment differences, stratification, and design of multiple-armed trials.This publication has 7 references indexed in Scilit:
- Confidence intervals following group sequential testsControlled Clinical Trials, 1986
- Designs for group sequential testsControlled Clinical Trials, 1984
- Repeated confidence intervals for group sequential clinical trialsControlled Clinical Trials, 1984
- A Multiple Testing Procedure for Clinical TrialsPublished by JSTOR ,1979
- Allocation of patients to treatment groups in a controlled clinical studyBritish Journal of Cancer, 1978
- Monitoring Treatment Differences in Long-Term Clinical TrialsBiometrics, 1977
- Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and designBritish Journal of Cancer, 1976