The Design and Analysis of Sequential Clinical Trials

In sequential clinical trials, data from patients treated at the beginning of a trial can be analyzed while the trial is still in progress and subsequent patients can be recruited. This analysis provides stopping rules whereby the number of patients involved can be limited without affecting the results.

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This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results. Emphasis is placed on the triangular test and other procedures based on straight line stopping boundaries. These methods allow for frequent or occasional interim analyses and permit the analysis of a wide variety of patient responses. Alternative procedures are also covered in detail, and these include -spending function methods, repeated confidence intervals and Bayesian approaches to sequential clinical trials.