ABSTRACT

Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures

chapter 1|22 pages

Introduction

chapter 2|24 pages

Protocol Amendment

chapter 3|28 pages

Adaptive Randomization

chapter 4|14 pages

Adaptive Hypotheses

chapter 5|18 pages

Adaptive Dose-Escalation Trials

chapter 6|30 pages

Adaptive Group Sequential Design

chapter 7|24 pages

Adaptive Sample Size Adjustment

chapter 8|12 pages

Adaptive Seamless Phase II/III Designs

chapter 9|22 pages

Adaptive Treatment Switching

chapter 10|16 pages

Bayesian Approach

chapter 11|28 pages

Clinical Trial Simulation

chapter 12|16 pages

Case Studies