Key Statistical Concepts in Clinical Trials for Pharma
Key Statistical Concepts in Clinical Trials for Pharma By J. Rick Turner
English | PDF | 2012 | 66 Pages | ISBN : 1461416612 | 2.24 MB
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.