Textbook of Clinical Trials in Oncology

"This highly anticipated book focuses on clinical trials in oncology, ranging from early, middle, and late phase trials to advanced topics such as precision medicine and immunotherapy. This textbook is expected to be extremely useful for statisticians and investigators who have been doing clinical trials for years, and for future clinical researchers and statisticians who are eager to learn about the design, conduct, analysis, and interpretation of clinical trials in oncology.

We strongly recommend this textbook for four reasons. First, it covers multiple stages of clinical trials in oncology, from early, middle, to late development. Second, it examines various designs of clinical trials, including traditional study designs, flexible designs, and SMART (Sequential Multiple Assignment Randomized Trials) designs. Third, it gives insights into unique aspects of clinical trials in oncology compared with other therapeutic areas, such as time-to-event endpoints and censoring. Fourth, it consists of different types of materials that are suitable to different groups of readers, with some materials for readers who like to have an aerial view of the practical considerations and the other materials for readers who like to have deep understanding to motivate their theoretical research. In the following, we explain these four reasons in detail...To summarize, because of the above four reasons, we strongly recommend this book to clinical researchers and statisticians who are interested in the development, design, conduct and analysis of oncology clinical trials. This book is well-balanced between practical considerations and statistical theories involved in oncology clinical trials. We believe that this book will help advance the design and analysis of oncology clinical trials with the ultimate goal to improve the care of oncology patients and their quality of life."
- Man Jin and Yixin Fang, Journal of Biopharmaceutical Statistics, November 2019

"This highly anticipated book focuses on clinical trials in oncology, ranging from early, middle, and late phase trials to advanced topics such as precision medicine and immunotherapy. This textbook is expected to be extremely useful for statisticians and investigators who have been doing clinical trials for years, and for future clinical researchers and statisticians who are eager to learn about the design, conduct, analysis, and interpretation of clinical trials in oncology.

We strongly recommend this textbook for four reasons. First, it covers multiple stages of clinical trials in oncology, from early, middle, to late development. Second, it examines various designs of clinical trials, including traditional study designs, flexible designs, and SMART (Sequential Multiple Assignment Randomized Trials) designs. Third, it gives insights into unique aspects of clinical trials in oncology compared with other therapeutic areas, such as time-to-event endpoints and censoring. Fourth, it consists of different types of materials that are suitable to different groups of readers, with some materials for readers who like to have an aerial view of the practical considerations and the other materials for readers who like to have deep understanding to motivate their theoretical research. In the following, we explain these four reasons in detail...To summarize, because of the above four reasons, we strongly recommend this book to clinical researchers and statisticians who are interested in the development, design, conduct and analysis of oncology clinical trials. This book is well-balanced between practical considerations and statistical theories involved in oncology clinical trials. We believe that this book will help advance the design and analysis of oncology clinical trials with the ultimate goal to improve the care of oncology patients and their quality of life."
- Man Jin and Yixin Fang, Journal of Biopharmaceutical Statistics, November 2019

"This book offers a comprehensive presentation of the statistical methods and issues connected with clinical trials in oncology...I would recommend this book to those who are new to the field of clinical trials in oncology and those who would like to learn about its specifics. The book covers a vast range of topics, which on its own illustrates how broad and dynamic the statistical methodology applied in oncology is...Individual chapters of the book are written by different authors. Therefore, each chapter is written by someone who is an expert in their field and can enrich the description of the methods with much appreciated insight on what is really used in practice and what the advantages and disadvantages of the methods are...Struggling with understanding some medical terms I found using the National Cancer Institute Dictionary of Cancer Terms very helpful when reading the book."
- Eva Kielkowská, ISCB News, July 2020