Statistical Thinking for Non-Statisticians in Drug Regulation
eBook - ePub

Statistical Thinking for Non-Statisticians in Drug Regulation

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  3. Available on iOS & Android
eBook - ePub

Statistical Thinking for Non-Statisticians in Drug Regulation

About this book

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION

Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices.

Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author's years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry.

The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes:

  • A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9
  • Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis
  • Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience

Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

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Yes, you can access Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay in PDF and/or ePUB format, as well as other popular books in Medicine & Biostatistics. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Wiley-Blackwell
Year
2022
Print ISBN
9781119867388
eBook ISBN
9781119867401
Edition
3
Topic
Medicine
Subtopic
Biostatistics

Table of contents

  1. Cover
  2. Table of Contents
  3. Title Page
  4. Copyright Page
  5. Preface to the third edition
  6. Preface to the second edition
  7. Preface to the first edition
  8. Abbreviations
  9. CHAPTER 1: Basic ideas in clinical trial design
  10. CHAPTER 2: Sampling and inferential statistics
  11. CHAPTER 3: Confidence intervals and p‐values
  12. CHAPTER 4: Tests for simple treatment comparisons
  13. CHAPTER 5: Adjusting the analysis
  14. CHAPTER 6: Regression and analysis of covariance
  15. CHAPTER 7: Intention‐to‐treat, analysis sets and missing data
  16. CHAPTER 8: Estimands
  17. CHAPTER 9: Power, sample size and clinical relevance
  18. CHAPTER 10: Multiple testing
  19. CHAPTER 11: Non‐parametric and related methods
  20. CHAPTER 12: Equivalence and non‐inferiority
  21. CHAPTER 13: The analysis of survival data
  22. CHAPTER 14: Interim analysis and data monitoring committees
  23. CHAPTER 15: Bayesian statistics
  24. CHAPTER 16: Adaptive designs
  25. CHAPTER 17: Observational studies
  26. CHAPTER 18: Meta‐analysis and network meta‐analysis
  27. CHAPTER 19: Methods for safety analysis, safety monitoring and assessment of benefit‐risk
  28. CHAPTER 20: Diagnosis
  29. CHAPTER 21: The role of statistics and statisticians
  30. References
  31. Index
  32. End User License Agreement