Description
Book SynopsisThe 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.
Trade Review'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
Table of ContentsAbout 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.
