Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly...
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine....
This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical...
This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a text...
Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoints/treatments, and confirmative biomarker-based phase III trials with interim monitoring and adaptation.
Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoin...