Key Statistical Concepts in Clinical Trials for Pharma

✍ Scribed by J. Rick Turner (auth.)

• Publisher: Springer-Verlag New York
• Year: 2012
• Tongue: English
• Leaves: 66
• Series: SpringerBriefs in Pharmaceutical Science & Drug Development
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Front Matter....Pages i-ix
Setting the Scene....Pages 1-10
Analyzing Safety Data....Pages 11-21
Assessing Efficacy Data....Pages 23-32
Confidence Intervals: Additional Commentary....Pages 33-40
Meta-Methodology....Pages 41-49
Benefit–Risk Estimation....Pages 51-58
Back Matter....Pages 59-61

✦ Subjects

Biomedicine general; Pharmaceutical Sciences/Technology