Scott Evans, Naitee Ting

Fundamental Concepts for New Clinical Trialists (eBook, PDF)

• Format: PDF

Produktbeschreibung

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 proper reporting of clinical trial results in the medical literature. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 368
• Erscheinungstermin: 4. November 2015
• Englisch
• ISBN-13: 9781498767101
• Artikelnr.: 57534209

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.

Inhaltsangabe

Background: Clinical Trials. Product Development Process. Regulatory Review
Organizations. Clinical Trial Statisticians. Scientific and Practical
Issues: General Considerations in Clinical Trial Design. Clinical Trial
Designs. Interim Data Monitoring. Analysis Considerations. Analysis of
Safety, Benefit:Risk, and Quality of Life. Publishing Trial Results.
Appendix. Index.