ABSTRACT

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip

chapter 3|20 pages

Bayesian Approach for Adaptive Design

chapter 5|26 pages

From Group Sequential to Adaptive Designs

chapter 9|20 pages

Classical Dose-Finding Trial

chapter 10|24 pages

Improving Dose-Finding: A Philosophic View

chapter 11|16 pages

Adaptive Dose-Ranging Studies

chapter 12|24 pages

Seamless Phase I/II Designs

chapter 13|8 pages

Phase II/III Seamless Designs

chapter 16|14 pages

Hypothesis-Adaptive Design

chapter 20|26 pages

Adaptive Infrastructure

chapter 21|10 pages

Independent Data Monitoring Committees

chapter 22|12 pages

Targeted Clinical Trials

chapter 24|18 pages

Adaptive Trial Simulation

chapter 25|16 pages

Efficiency of Adaptive Designs

chapter 26|14 pages

Case Studies in Adaptive Design

chapter 27|11 pages

Good Practices for Adaptive Clinical Trials