Main description:

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

Contents:

The need for this book. Selection of endpoints. Co-primary Endpoints. Surrogate Endpoints. Innovative Phase I. Phase II. Phase II Biomarker, basket trials. Sample Size for phase III. Multi-Arm trials. Non-inferiority trials. Cure Rate. Design and Analysis of Immunotherapy Trials Data Monitoring Superiorirty and Futility Monitoring. Competing Risks. Missing Data. Multiple Comparison. Biomarker-based clinical trials. Adaptive designs. Trials designs for rare diseases in oncology. Prognostic Models. Validation Approaches. Identification of Predictive Markers. Subgroup Analysis. Statistical Issues in Genomic Studies. Developing and Validation of Signature