Main description:

This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

Contents:

New designs for phase I dose finding studies.- Phase II/III designs for trials.- Design issues for clinical studies with genomic measurements.- Designing studies with longitudinal measurements subject to dropout.- Issues in sample size re-estimation.- Adaptive designs.- The design of non-inferiority trials.- Issues in the design of HIV prevention trials.- Randomization algorithms.- Sequential designs for phase III studies.- Case studies of difficult designs.- Ethical issues in the design of trials.- Index.