Introduction to Adaptive Trial Designs and Master Protocols

ISBN-13: 9781108926980 / Miękka / 2023 / 256 str.

J. Kyle Wathen

Opis

A unique and practical high-level introductory guide to the emerging field of adaptive trial designs, platform trials, and master protocols.

Recenzje

'This book fulfils an important need, providing a broad overview of recent work in innovative approaches to clinical trials. It covers two major types of innovative trial design that are becoming more widespread in clinical research: adaptive designs and master protocols. For readers who wish to delve into more depth, it provides a thorough review of literature on the topic. It also showcases available software, both commercial and free, and provides many real case studies of where the designs have been used in real trials. The book is written by three experts in the field who understand well the benefits and limitations of these approaches. It is relevant to those who work in academic trials as well as the pharmaceutical industry. I would highly recommend it as a great resource for clinical trialists who want to understand these approaches better.' James Wason, Professor of Biostatistics, Newcastle University

Spis treści

About the Author; Preface; Part I. History and Introduction to Clinical Trial Research: 1. Introduction to Clinical Trial Research; 2. History of Clinical Trial Research. Part II. Basic Ingredients for Adaptive Trial Designs and Common Types: 3. Characteristics and Principles of Adaptive Trial Designs; 4. Common Types of Adaptive Trial Designs; 5. Clinical Trial Simulations; Part III. Basic Ingredients for Master Protocols: 6. Characteristics and Principles of Master Protocols; 7. Platform Trials; 8. Basket and Umbrella Trials; Part IV. Case Studies of Adaptive Trial Designs and Master Protocols; 9. Case Studies of Adaptive Trial Designs; 10. Case Studies of Platform Trials; 11. Case Studies of Basket and Umbrella Trials; 12. Standards and Guidelines for Adaptive Trial Designs and Master Protocols; Part V. A Practical Guide to Adaptive Trial Designs and Master Protocols: 13. Common Misconceptions of Adaptive Trial Designs and Master Protocols; 14. Practical Considerations for Adaptive Trial Designs and Master Protocols.