Overview

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.

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9781108926980

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Reviews

'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

Author Information

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. Edward J. Mills is a Professor in the Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences at McMaster University in Canada. J. Kyle Wathen is Vice President of Scientific Strategy and Innovation at Cytel Inc.

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