Statistical Monitoring of Clinical Trials

All three of this work's authors are experts in adaptive methodology for clinical trials. Here, they offer an accessible, incremental approach to understanding Brownian motion as related to clinical trials that will develop insight into not only monitoring, but many other statistical issues germane to clinical trials.

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials. The main body of the chapters is accessible to anyone with knowledge of a standard mathematical statistics text. More mathematically advanced readers will find rigorous developments in appendices at the end of chapters. Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials.

Offers an accessible, incremental approach to understanding Brownian motion as related to clinical trials Shows how to use the B-value approach to monitoring different types of trials All three authors are experts in adaptive methodology for clinical trials Provides insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials Includes supplementary material: sn.pub/extras

Contenu
A General Framework.- Power: Conditional, Unconditional, and Predictive.- Historical Monitoring Boundaries.- Spending Functions.- Practical Survival Monitoring.- Inference Following a Group-Sequential Trial.- Options When Brownian Motion Does Not Hold.- Monitoring for Safety.- Bayesian Monitoring.- Adaptive Sample Size Methods.- Topics Not Covered.- Appendix I: The Logrank and Related Tests.- Appendix II: Group-Sequential Software.