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This text describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. It offers first-hand perspectives on real-world issues, such as common and challenging clinical trial designs and the pro
With complete coverage of issues in all phases of clinical trials, including design, data monitoring, analyses, interpretation, and reporting, this book provides an overview of fundamental concepts important to statisticians working with clinical trials. It examines issues related to product development and regulation, and then discusses the attributes that statisticians can acquire to maximize their contribution to the research. The co-authors draw on their experience in industry and academia to provide balanced, practical guidance on how statisticians can apply their knowledge to address real world clinical trial issues.
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