There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology.
Cutting-edge topics with appropriate technical background
Built around case studies which give the work a “hands-on” approach
Real examples of flaws in previously reported clinical trials and how to avoid them
Access to statistical code on the book’s website
Chapters written by internationally recognized statisticians from academia and pharmaceutical companies
Carefully edited to ensure consistency in style, level, and approach
Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others