Pharma Focus Asia
KP - Sustainable Packaging Solutions

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials

Pages: 301

Publisher: Springer International Publishing

Year of Publication: 2016

Author(s) : Gernot Wassmer, Werner Brannath

Book Description:

This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-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 and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application.

The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

http://www.springer.com/gp/book/9783319325606

Latest Issue
Get instant
access to our latest e-book
MFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Gibco Adherent Kidney Media PanelCPHI Korea 2024Equinix accelerated medical research...CHEMICAL INDONESIA 2024Thermofisher - Antibody Therapeutic PolishingINALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024
Searching for an end-to-end patient tech solution?