Design and Analysis of Clinical Trials: Concepts and Methodologies (Google eBook)

Front Cover
John Wiley & Sons, 2004 - Mathematics - 729 pages
1 Review
Praise for the First Edition of Design and Analysis of Clinical Trials

"An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area."
–Statistical Methods in Medicine

A complete and balanced presentation now revised, updated, and expanded

As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH).

Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as:

  • Clinical trials and regulations, especially those of the ICH
  • Clinical significance, reproducibility, and generalizability
  • Goals of clinical trials and target population
  • New study designs and trial types
  • Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities

Also, three entirely new chapters cover:

  • Designs for cancer clinical trials
  • Preparation and implementation of a clinical protocol
  • Data management of a clinical trial

Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references–280 of them new to the Second Edition–to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

  

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Contents

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VI
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LIX
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LX
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Page 22 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 12 - Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man...
Page 22 - ... substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. . . . [T]he term "substantial evidence...
Page 23 - If the protocol does not contain a description of the proposed methods of analysis, the study report should describe how the methods used were selected. (2) The study uses a design that permits a valid comparison with a control to provide a quantitative assessment of drug effect. The protocol for the study and report of results should describe the study design precisely; for example, duration of treatment periods, whether treatments are parallel, sequential, or crossover, and whether the sample size...
Page 12 - biological product" as "any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product ' ' * applicable to the prevention, treatment, or cure of diseases or injuries of man...
Page 14 - Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase...

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About the author (2004)

SHEIN-CHUNG CHOW, PhD, is currently Vice President of Biostatistics and Clinical Data Management for Millennium Pharmaceuticals, Inc., in Cambridge, Massachusetts.

JEN-PEI LIU, PhD, is currently Professor of Statistics for the National Cheng kung University in Tainan, Taiwan, and an investigator for the National Health Research Institutes in Taipei, Taiwan. Both authors have extensive background experience in industry and academia, and, collectively, have published well over a dozen books in their respective fields of study.

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