Statistical Design, Monitoring, and Analysis of Clinical Trials,
Second Edition concentrates on the biostatistics component of clinical
trials. This new edition is updated throughout and includes five new
chapters.
Developed from the authors' courses taught to public health and medical
students, residents, and fellows during the past 20 years, the text
shows how biostatistics in clinical trials is an integration of many
fundamental scientific principles and statistical methods. The book
begins with ethical and safety principles, core trial design concepts,
the principles and methods of sample size and power calculation, and
analysis of covariance and stratified analysis. It then focuses on
sequential designs and methods for two-stage Phase II cancer trials to
Phase III group sequential trials, covering monitoring safety, futility,
and efficacy. The authors also discuss the development of sample size
reestimation and adaptive group sequential procedures, phase 2/3
seamless design and trials with predictive biomarkers, exploit multiple
testing procedures, and explain the concept of estimand, intercurrent
events, and different missing data processes, and describe how to
analyze incomplete data by proper multiple imputations.
This text reflects the academic research, commercial development, and
public health aspects of clinical trials. It gives students and
practitioners a multidisciplinary understanding of the concepts and
techniques involved in designing, monitoring, and analyzing various
types of trials. The book's balanced set of homework assignments and
in-class exercises are appropriate for students and researchers in
(bio)statistics, epidemiology, medicine, pharmacy, and public health.
