Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

• Main Authors: Wassmer, Gernot (Author), Brannath, Werner (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2016.
• Series: Springer Series in Pharmaceutical Statistics,
• Subjects: Statistics.; Pharmaceutical technology.; Pharmacy.; Biostatistics.; Statistics for Life Sciences, Medicine, Health Sciences.; Drug Safety and Pharmacovigilance.; Pharmaceutical Sciences/Technology.

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 contr...

Table of Contents:

• Part I Group Sequential Designs
• Repeated Significance Tests: Procedures with Equally Sized Stages
• Procedures with Unequally Sized Stages
• Confidence Intervals, p -Values, and Point Estimation
• Applications
• Part II Adaptive Confirmatory Designs with a Single Hypothesis: Adaptive Group Sequential Tests
• Decision Tools for Adaptive Designs
• Estimation and p-Values for Two-stage Adaptive Designs
• Adaptive Designs with Survival Data
• Part III Adaptive Designs with Multiple Hypotheses: Multiple Testing in Adaptive Designs
• Applications and Case Studies
• Appendix - Software for Adaptive Designs
• Index.