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Chapman and Hall/Crc Biostatistics Ser.: Fundamental Concepts for New Clinical Trialists by Naitee Ting and Scott Evans (2015, Hardcover)
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Author: Scott Evans, Naitee Ting ISBN 10: 1420090879. Will be clean, not soiled or stained.
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About this product
Product Identifiers
PublisherCRC Press LLC
ISBN-101420090879
ISBN-139781420090871
eBay Product ID (ePID)66811515
Product Key Features
Number of Pages348 Pages
LanguageEnglish
Publication NameFundamental concepts for New Clinical Trialists
SubjectClinical Medicine, Probability & Statistics / General, Pharmacology
Publication Year2015
TypeTextbook
AuthorNaitee Ting, Scott Evans
Subject AreaMathematics, Medical
SeriesChapman and Hall/Crc Biostatistics Ser.
FormatHardcover
Dimensions
Item Height1 in
Item Weight24.1 Oz
Item Length9.4 in
Item Width6.5 in
Additional Product Features
Intended AudienceScholarly & Professional
LCCN2016-304353
Reviews"The book focuses on important concepts and promotes 'thinking clinical trials', and it is very readable. This book targets both statisticians and non-statisticians and wishes to facilitate better communication between them. I found that some chapters are especially useful for statisticians involved in clinical trials. . . Dr Evans uses this book as part of his 'Principles of Clinical Trials' course at the Harvard School of Public Health. Overall, it is an exciting book!" ~ International Statistical Review (2017), "The book focuses on important concepts and promotes 'thinking clinical trials', and it is very readable. This book targets both statisticians and non-statisticians and wishes to facilitate better communication between them. I found that some chapters are especially useful for statisticians involved in clinical trials. . . Dr Evans uses this book as part of his 'Principles of Clinical Trials' course at the Harvard School of Public Health. Overall, it is an exciting book!" ~ International Statistical Review "Statisticians learn the easy part of designing and analyzing clinical trials in class, but we usually learn the hard parts by our post-graduate failures. This book offers a course outline and valuable set of instructions to describe how to avoid many lessons we might otherwise have to learn the hard way." ~The International Biometric Society
Dewey Edition22
Series Volume Number77
IllustratedYes
Dewey Decimal615.70724
Table Of ContentBackground 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 MonitoringBoards 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® Drug Label Index References appear at the end of each chapter.
SynopsisFundamental Concepts for New Clinical Trialists 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. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.
LC Classification NumberR853.C55E936 2016
