Reliability and Risk: A Bayesian Perspective

bridge (BB) processes. The first chapter introduces the rationale, the history, and the notions behind the statistical monitoring of clinical trials. In Chapters 2 and 3, the author overviews some probability and statistics concepts that are needed for the rest of the book. In Chapters 4 and 5, the Brownian motion process and fundamentals for monitoring its path via the alpha-spending function approach of Lan and DeMets (1983) are discussed and the connection with boundaries for monitoring clinical trials is made. The important concept of conditional power approach for monitoring a trial is discussed in Chapter 6 by means of the BB process. Chapter 7 explains the concept of monitoring safety endpoints and stopping for futility (i.e., terminating the trial when clinically significant results are unlikely to be observed at the end of the trial). Both concepts are exposed through the conditional power approach. Finally, the author concludes with Chapter 8 concerning the Bayesian group sequential techniques for monitoring clinical trials. The author pushes to the Appendices several unavoidable mathematical derivations concerning the computation of monitoring boundaries for BM and BB processes. As is the case with almost any first edition, this book has its share of minor typos, specially in the bibliographies. Apart from this, there are several important subjects not covered in the book such as sample size calculations and adaptive group sequential monitoring techniques, which recently gained momentum among clinical trial investigators. Also, the book lacks real examples using real-life data sets. These points will, hopefully, be rectified in future editions.