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.
J. Rick Turner, PhD, is an experimental research scientist and clinical trialist, and currently Senior Scientific Director, Integrated Cardiovascular Safety, Quintiles. With his colleagues, he provides Sponsors with consultation, strategic and regulatory insights, and operational support during cardiac safety assessments throughout clinical development programs. He is particularly interested in the development of drugs for Type 2 Diabetes Mellitus and obesity.Dr Turner is also a Senior Fellow at the Center for Medicine in the Public Interest (New York) and Editor-in-Chief of the DIA’s peer-reviewed
Drug Information Journal. He has published 12 previous books, 65 peer-reviewed papers, and many articles in professional journals. His books include:
· Turner JR, 2011, A Concise Guide to Clinical Trials. Chapel Hill, NC: Turner Medical Communications LLC.
· Turner JR, 2010, New Drug Development: An Introduction to Clinical Trials, 2nd Edition. New York: Springer.
· Turner JR, Durham TA, 2009, Integrated Cardiac Safety: Assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance. Hoboken, NJ: John Wiley & Sons.
· Durham TA, Turner JR, 2008, Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press.
Dr Turner is also a Senior Fellow at the Center for Medicine in the Public Interest (New York) and Editor-in-Chief of the DIA’s peer-reviewed
Drug Information Journal. He has published 12 previous books, 65 peer-reviewed papers, and many articles in professional journals. His books include:
· Turner JR, 2011, A Concise Guide to Clinical Trials. Chapel Hill, NC: Turner Medical Communications LLC.
· Turner JR, 2010, New Drug Development: An Introduction to ClinicalTrials, 2nd Edition. New York: Springer.
· Turner JR, Durham TA, 2009, Integrated Cardiac Safety: Assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance. Hoboken, NJ: John Wiley & Sons.
· Durham TA, Turner JR, 2008, Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press.
