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Design and Analysis of Clinical Trials
Concepts and Methodologies
Second Edition
by Shein-Chung Chow
and Jen-Pei Liu

Design and Analysis of Clinical Trials provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements.

Design and Analysis of Clinical Trials bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner.

Design and Analysis of Clinical Trials features 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
  • 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.

Design and Analysis of Clinical Trials emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references

Design and Analysis of Clinical Trials 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.

Contents:

  1. Introduction
  2. Basic Statistical Concepts
  3. Basic Design Considerations
  4. Randomization and Blinding
  5. Designs for Clinical Trials
  6. Designs for Cancer Clinical Trials
  7. Classification of Clinical Trials
  8. Analysis of Continuous Data
  9. Analysis of Categorical Data
  10. Censored Data and Interim Analysis
  11. Sample Size Determination
  12. Issues in Efficacy Evaluation
  13. Safety Assessment
  14. Preparation and Implementation of a Clinical Protocol
  15. Clinical Data Management
Index

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Design and Analysis of Clinical Trials
Concepts and Methodologies
Second Edition
by Shein-Chung Chow and Jen-Pei Liu

729 pages • $174.00 + shipping
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