Fundamental Concepts for New Clinical Trialists - Evans, Scott; Ting, Naitee
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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.…mehr

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Produktbeschreibung
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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Autorenporträt
Dr. Scott Evans teaches clinical trials at Harvard University, where he is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group, an NIH-funded clinical trials network. He serves on a U.S. FDA Advisory Committee and several data monitoring committees for industry and NIH-sponsored clinical trials. He has been a recipient of the Mosteller Statistician of the Year Award and is a fellow of the American Statistical Association. Dr. Evans is a visiting professor at the Department of Medical Statistics at Osaka University and serves as the executive editor for CHANCE and the editor-in-chief of Statistical Communications in Infectious Diseases. Dr. Naitee Ting has close to 30 years of experience in the pharmaceutical industry and currently works at Boehringer Ingelheim. He has also taught courses on clinical trials in the Department of Statistics at the University of Connecticut, University of Rhode Island, and Department of Biostatistics at Columbia University. He is a fellow of the American Statistical Association.