Key Statistical Concepts in Clinical Trials for Pharma [electronic resource]

• Tác giả: J. Rick Turner
• Ngôn ngữ: eng
• ISBN-13: 978-1461416623
• Ký hiệu phân loại: 610.72 Medicine and health
• Thông tin xuất bản: New York, NY : Springer New York : Imprint: Springer, 2012.
• Mô tả vật lý: IX, 61 p. 1 illus. , online resource.
• Bộ sưu tập: Metadata2
• ID: 291655
• Chủ đề: 1. Biology-Research; 2. Medicine-Research; 3. Pharmaceutical chemistry; 4. Biomedical Research; 5. Pharmaceutics

Tóm tắt

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.