Key Statistical Concepts in Clinical Trials for Pharma
Nonfiction, Health & Well Being, Medical, Specialties, Pharmacy, Science & Nature, Technology
| Author: | J. Rick Turner | ISBN: | 9781461416623 |
| Publisher: | Springer New York | Publication: | October 14, 2011 |
| Imprint: | Springer | Language: | English |
| Author: | J. Rick Turner |
| ISBN: | 9781461416623 |
| Publisher: | Springer New York |
| Publication: | October 14, 2011 |
| Imprint: | Springer |
| Language: | English |
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.
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.
