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Iris Pigeot, Statistical Monitoring of Clinical Trials. Fundamentals for Investigators by L. A. Moyé, Biometrics, Volume 63, Issue 4, December 2007, Pages 1300–1301, https://doi.org/10.1111/j.1541-0420.2007.00905_5.x
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Extract
The most challenging part of the monitoring of clinical trials relates to the question of whether a trial should be prematurely terminated due to early evidence of benefit, harm, or “futility.” This critical decision has to be made by the members of data monitoring committees (DMC) who may not fully understand the underlying statistical rules for early termination based on, e.g., group sequential designs and interim analyses. This task is therefore complex and conflicting, especially since no easy-to-read introductory material on this topic is available for clinical researchers. This gap is now filled by the book of Lemuel Moyé. The author explains the statistical monitoring procedures that are necessary to fulfil the task of a DMC, but the book is not intended to describe the work of DMCs in general. The book is written such that it can be understood without a sophisticated mathematical background. Numerous hypothetical examples illustrate the application of the presented stopping rules or monitoring guidelines. More technical sessions that need some basic knowledge in probability are indexed with a “*” in their title. In addition, derivations of formulae are moved to an appendix that also needs a background course in statistics to be fully understood.
