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Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug …
The book will look at issues related to the stepped wedge randomised controlled trials design. This is a design that is being increasingly used in the evaluation of …
A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect …
This is a cohesive and comprehensive book on statistical omics from a biopharmaceutical perspective which focuses on presenting statistical methods, including false discovery rate …
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design …
This book focuses on innovative designs that are easy to understand, easy to implement and conceptually intuitive. The author includes methods he recently developed plus ideas and …
This book focuses on current research and methodologies developed for re-engineering cancer clinical trials and also for "hot" areas in drug development trials such as adaptive …