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.

Key Features:

• • 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

About the Author

Contents

۱. Introduction to Clinical Trials
۲. Selection of Endpoints
۳. Innovative PhaseITrials
۴. Current Issues in Phase II Cancer Clinical Trials
۵. Design and Analysis of Immunotherapy Clinical Trials
۶. Adaptive Designs
۷. Sample Size Calculations for Phase III Trials in Oncology
۸. Non-Inferiority Trial
۹. Design of Multi-Arm,. Multi-Stage Trials in Oncology
۱۰. Multiple Comparisons, Multiple Primary Endpoints and Subpopulation Analysis
۱۱. Cluster Randomized Trials
۱۲. Statistical Monitoring of Safety and Efficacy
۱۳. Biomarker-Based Phase II and III Clinical Trials in Oncology
۱۴. Genomic Biomarker Clinical Trial Designs
۱۵. Trial Designs for Rare Diseases and Small Samples in Oncology
۱۶. Statistical Methods for Biomarker and Subgroup Evaluation in Oncology Trials
۱۷. Developing and Validating Prognostic Models of Clinical Outcomes
۱۸. High-Dimensional Penalized-Regression Models in Time-to-Event Clinical Trials
۱۹. Sequential, Multiple Assignment, Randomized Trials
۲۰. Assessing the Value of Surrogate Endpoints
۲۱. Competing Risks
۲۲. Cure Models in Cancer Clinical Trials
۲۳. Inten/al Censoring
۲۴. Methods for Analysis of Trials with Changes from Randomized Treatment
۲۵. The Analysis of Adverse Events in Randomized Clinical Trials
۲۶. Analysis of Quality of Life Outcomes in Oncology Trials
۲۷. Missing Data