Key Statistical Concepts in Clinical Trials for Pharma

  • J. Rick Turner

Table of contents

  1. Front Matter
    Pages i-ix
  2. J. Rick Turner
    Pages 1-10
  3. J. Rick Turner
    Pages 11-21
  4. J. Rick Turner
    Pages 23-32
  5. J. Rick Turner
    Pages 33-40
  6. J. Rick Turner
    Pages 41-49
  7. J. Rick Turner
    Pages 51-58
  8. Back Matter
    Pages 59-61

About this book

Introduction

This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.

Keywords

Clinical Trials Pharma Statistical Concepts Statistics

Authors and affiliations

  • J. Rick Turner
    • 1
  1. 1.Cardiac Safety ServicesQuintilesDurhamUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4614-1662-3
  • Copyright Information The Author (s) 2012
  • Publisher Name Springer, New York, NY
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4614-1661-6
  • Online ISBN 978-1-4614-1662-3
  • Series Print ISSN 1864-8118
  • Series Online ISSN 1864-8126
  • About this book
Industry Sectors
Biotechnology
Consumer Packaged Goods
Pharma