Introduction to Adaptive Trial Designs and Master Protocols

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

Jay J. H. Park (Author), Edward J. Mills (Author), J. Kyle Wathen (Author)

9781108926980, Cambridge University Press

Paperback / softback, published 6 April 2023

256 pages
23.4 x 15.6 x 1 cm, 0.33 kg

'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

This practical high-level guidebook offers an in-depth understanding of the newly emerging clinical trial designs in adaptive trial designs and master protocols. Both concise and readable without shying away from technical discussion, the book introduces the most innovative approaches in clinical trial research such as adaptive trial designs, master protocols, platform trial, basket trial, and umbrella trial designs. Featuring a revisionist history of clinical research before moving on to case-study based discussion and practical considerations from collective experience. The book enables readers to understand the strengths and limitations of these novel designs as well as their application to individual areas of research and clinical practice. Supplemented by real-world examples from the recent developments in medical research efficiency instigated by both personalized medicine and high-profile diseases like COVID-19 and cancer. The first book of its kind, it is the go-to resource for medical students and researchers working in clinical trial research.

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.

Subject Areas: Medicine: general issues [MB]