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Introduction to Statistics in Pharmaceutical Clinical Trials

Introduction to Statistics in Pharmaceutical Clinical Trials

Edited by Todd A Durham and J Rick Turner



A textbook that looks at study design, research methodology, statistical analysis and interpretation in clinical trials.

Published1st Mar, 2008
Dimensions246 x 189 mm
Page count240


Introduction to Statistics in Pharmaceutical Clinical Trials is presented in the context of clinical trials conducted during pharmaceutical drug development.   This novel approach teaches the computational steps needed to conduct analyses. It also provides a conceptual understanding of how these analyses provide information that forms the basis for decision making throughout the drug development process.   This textbook conveys:

  • why, and how data are collected in clinical studies.
  • how these data are summarized and analyzed.
  • what the results mean in the context of the clinical research question.
  • how the results are communicated to regulatory agencies and to the scientific and medical communities.

This book is invaluable to health professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.

  • The Discipline of Statistics: Introduction and Terminology
  • The Role of Clinical Trials in New Drug Development
  • Research Questions and Research Hypotheses
  • Study Design and Experimental Methodology
  • Data, Central Tendency and Variation
  • Probability, Hypothesis Testing and Estimation
  • Early-phase Clinical Trials
  • Confirmatory Clinical Trials: Safety Data I
  • Confirmatory Clinical Trials: Safety Data II
  • Confirmatory Trials: Analysis of Categorical Efficacy Data
  • Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data
  • Additional Statistical Considerations in Clinical Trials
  • Concluding Comments: Appendix: References


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