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About this product
- Author(s)Naitee Ting,Scott Evans
- PublisherTaylor & Francis Inc
- Date of Publication01/12/2011
- Series TitleChapman & Hall/CRC Biostatistics Series
- Series Part/Volume Number77
- Place of PublicationWashington
- Country of PublicationUnited States
- ImprintTaylor & Francis Inc
- Content Note38 black & white illustrations, 57 black & white tables
- Weight680 g
- Width156 mm
- Height235 mm
- Table Of ContentsBackground Clinical Trials Introduction Phases The Protocol Clinical Trial Registration Ethical Issues Product Development Process The Drug Label Nonclinical Development Clinical Development Regulatory Review Organizations Food and Drug Administration European Medicines Agency Guidances Clinical Trial Statisticians Roles of the Clinical Trial Statistician Important Attributes and Suggestions for Development Scientific and Practical Issues General Considerations in Clinical Trial Design General Design Issues in Clinical Trials Design Issues in Controlled Clinical Trials Special Issues Clinical Trial Designs Phase I Other Trial Designs Including Phase II and III Phase IV Interim Data Monitoring Data Monitoring Committees/Data Safety Monitoring Boards Interim Monitoring Methods Limitations and Extensions A Centralized Risk-Based Approach to Monitoring Analysis Considerations SAP Other Preparations for Analyses General Issues Report Writing Analysis of Safety, Benefit:Risk, and Quality of Life Safety Benefit:Risk Evaluation Quality of Life Publishing Trial Results Guidelines for Reporting Clinical Trial Results Reporting the Results of Subgroup Analyses Reporting Benefits and Risks Reporting NI Trials Reporting Adaptive Designs Reporting Bayesian Designs Appendix: Excerpts from the Lipitor(R) Drug Label Index References appear at the end of each chapter.
- Author BiographyDr. 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.
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