ABSTRACT

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini

chapter 1|22 pages

Introduction

chapter 2|20 pages

Protocol Amendment

chapter 3|26 pages

Adaptive Randomization

chapter 4|14 pages

Adaptive Hypotheses

chapter 5|20 pages

Adaptive Dose-Escalation Trials

chapter 6|30 pages

Adaptive Group Sequential Design

chapter 8|24 pages

Adaptive Sample Size Adjustment

chapter 9|22 pages

Two-Stage Adaptive Design

chapter 10|20 pages

Adaptive Treatment Switching

chapter 11|16 pages

Bayesian Approach

chapter 12|18 pages

Biomarker Adaptive Trials

chapter 13|16 pages

Target Clinical Trials

chapter 14|12 pages

Sample Size and Power Estimation

chapter 15|26 pages

Clinical Trial Simulation

chapter 17|16 pages

Case Studies