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Biometrika 1979 66(3):443-452; doi:10.1093/biomet/66.3.443
© 1979 by Biometrika Trust
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The analysis of sequential clinical trials

JOHN WHITEHEAD and DAVID JONES

Department of Applied Statistics, University of Reading
Department of Community Medicine, Westminster Medical School London

The conduct of a sequential clinical trial is considered in two distinct stages, the planning of the trial and the analysis of the results. Tests based on straight line stopping boundaries are considered. The planning stage is described in terms of existing theory and results are presented which allow significance levels to be quoted and interval estimates to be given at the analysis stage. Tables for use in the calculation of significance levels are included. The accuracy of large sample results is assessed by means of oomputer simulation.

Key Words: Clinical trial • Confidence interval • Estimation • Large sample test • Log rank test • Modified Wilcoxon test • Sequential analysis • Significance level


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