Introduction to Adaptive Trial Designs and Master Protocols
Introduction to Adaptive Trial Designs and Master Protocols
Edward J. Mills, McMaster University, Ontario
J. Kyle Wathen, Cytel, Cambridge, Massachusetts
$42.00
USDThis 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.
- The first student-focused introduction to adaptive trial designs and master protocols, making it the ideal resource for graduate students and researchers with limited experience of the subject
- Introduces, and provides current case studies for, each type of clinical trial for those new to this area of research, allowing for quick insight into adaptive designs and master protocols
- Addresses the regulatory priorities and debates occurring in this real-time moving landscape, highlighting the status of agencies in terms of understanding adaptive trials and master protocols and areas of ongoing debate between regulators and the research community
Reviews & endorsements
‘A delightful, easy-to-read and must-have primer for anyone offering a course on basic concepts, ingredients, attributes, and different types of, including common misconceptions and practical considerations for, adaptive clinical trials and master protocols.’ Lehana Thabane, Professor, Department of Health Research Methods, Evidence, and Impact, McMaster University, Canada
‘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
Product details
June 2023Paperback
9781108926980
256 pages
234 × 156 × 10 mm
0.33kg
Available
Table of Contents
- 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.
