Introduction to Statistics in Pharmaceutical Clinical Trials

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Introduction to Statistics in Pharmaceutical Clinical Trials

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Introduction to Statistics in Pharmaceutical Clinical Trials

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ISBN
9780853697145
Author
Todd A Durham and J Rick Turner
Published by
Pharmaceutical Press
Publication Date
March 2008
Format
Paperback
Extent
240 pages
Dimensions
189 x 246 mm

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.

All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics.

Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to 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. 
  1. The Discipline of Statistics: Introduction and Terminology
  2. The Role of Clinical Trials in New Drug Development
  3. Research Questions and Research Hypotheses
  4. Study Design and Experimental Methodology
  5. Data, Central Tendency and Variation
  6. Probability, Hypothesis Testing and Estimation
  7. Early-phase Clinical Trials
  8. Confirmatory Clinical Trials: Safety Data I
  9. Confirmatory Clinical Trials: Safety Data II
  10. Confirmatory Trials: Analysis of Categorical Efficacy Data
  11. Confirmatory Clinical Trials of Analysis of Continuous Efficacy Data
  12. Additional Statistical Considerations in Clinical Trials
  13. Concluding Comments: Appendix: References


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