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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.
List 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.
About the author
Jay J. H. Park is an Assistant Professor in the Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences at McMaster University in Canada.
Summary
The first introductory guide to the fast-paced and emerging field of research, equipping readers with the knowledge to critically interpret and plan adaptive clinical trials and master protocols. An invaluable text for medical students and researchers, featuring a history of clinical trial research, case studies and a practical guide.
