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Analysis of Clinical Trials Using SAS by Geert Molenberghs, Walter W. Offen, Christy Chuang-Stein, Alex Dmitrienko

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Interim Data Monitoring     4

 

 

4.1 Introduction

4.2 Repeated Significance Tests

4.3 Stochastic Curtailment Tests

 

 

This chapter reviews sequential data monitoring strategies in clinical trials. It introduces a class of group sequential tests (known as repeated significance tests) that are widely used in the assessment of interim findings in clinical applications. The first part of the chapter provides a detailed review of the process of designing group sequential trials and also discusses flexible procedures for monitoring clinical trial data. The second part of the chapter reviews popular approaches to constructing futility-testing procedures in clinical trials. These approaches are based on frequentist (conditional power), mixed Bayesian-frequentist ...

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