Design and Analysis of Clinical Trials for Predictive Medicine

To say this is an extremely timely book would be a gross understatement. The editors have assembled an impressive series of articles that address many of the major methodological issues confronting researchers who are attempting to not only identify valuable medical treatments but to determine which subsets of patients will benefit from these treatments. These issues are particularly important in cancer research, where treatments are often burdensome, toxic, and expensive; one does not want to treat large numbers of patients when only a few will benefit ...[this] would be a very valuable resource for anyone in, or moving into, the area of clinical trials for developing targeted therapies. Because the chapters steer away from highly technical discussions, I would recommend this book to clinicians as well as statisticians who are working in this challenging and developing area of research. -Susan Ellenberg, Journal of the ~American Statistical Association Design and Analysis of Clinical Trials for Predictive Medicine addresses a necessity for precision medicine: identifying and testing molecular biomarkers for their ability to predict the effect of treatments on specific patient populations. ~Journal of Clinical Research Best Practices, December 2015 ... a very good collection of relevant topics and methods, which have been published and applied in the field of personalized medicine from a clinical development perspective. The editors of this book are experts in the field and have published extensively on these topics. ... a useful reference for biostatisticians and researchers involved in the design and analyses of biomarker integrated clinical trials. ~Arunava Chakravartty, Journal of Biopharmaceutical Statistics ... a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students. ~Zentralblatt MATH The book, edited by three leading experts in methodology of clinical trials, includes 18 chapters divided in six sections written by 36 statisticians and other methodologists with longstanding experience in academia, industry, funding agencies, and regulatory authorities. The book covers all aspects of clinical trial design from the early stages of assay validation to later phase I, II, and III trials. It also provides guidance on statistical methods for the analysis of data generated at the different stages. This comprehensive coverage of the natural history of drug and biomarker development can help researchers better understand the challenges encountered by their colleagues in previous or subsequent phases of this pipeline. Despite being an edited book, the concepts are well-integrated across the chapters and, most of the time, the transition from one topic to the other is done in a natural way for the reader. . . . I found the book a very informative introduction to a new kind of clinical trials that will become more common in the future years as the community intensifies the pursuit of individualized treatments. ~The International Biometric Society In reading the book, one gains somewhat of a double education , in that through reading about the statistical concepts used in a setting, one's understanding of the disease biology is enriched, and vice versa. ~Emma YuWang, International Society for Clinical Biostatistics