Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

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Synopsis
This book provides an up-to-date review of the general principles of andtechniques for confirmatory adaptive designs. Confirmatory adaptive designs area generalization of group sequential designs. With these designs, interimanalyses are performed in order to stop the trial prematurely undercontrol of the Type I error rate. In adaptive designs, it is also permissibleto perform a data-driven change of relevant aspects of the study design atinterim stages. This includes, for example, a sample-size reassessment, atreatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion andstill represents a rapidly growing field of statistical research. This bookdescribes adaptive design methodology at an elementary level, while alsoconsidering designing and planning issues as well as methods for analyzing anadaptively planned trial. This includes estimation methods and methods for thedetermination of an overall p-value. Part I of the book provides the groupsequential methods that are necessary for understanding and applying theadaptive design methodology supplied in Parts II and III of the book. The bookcontains many examples that illustrate use of the methods for practicalapplication. The book is primarily written for applied statisticians from academiaand industry who are interested in confirmatory adaptive designs. It is assumedthat readers are familiar with the basic principles of descriptive statistics,parameter estimation and statistical testing. This book will also be suitablefor an advanced statistical course for applied statisticians or clinicians witha sound statistical background.
Copyright:
2016

Book Details

Book Quality:
Publisher Quality
ISBN-13:
9783319325620
Publisher:
Springer International Publishing, Cham
Date of Addition:
Copyrighted By:
Springer
Adult content:
No
Language:
English
Has Image Descriptions:
No
Categories:
Nonfiction, Medicine
Submitted By:
Bookshare Staff
Usage Restrictions:
This is a copyrighted book.

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