Key Statistical Concepts in Clinical Trials for Pharma

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 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.

• Setting the Scene.- Analyzing Safety Data.- Assessing Efficacy Data.- Confidence Intervals: Additional Commentary.- Meta-methodology.- Benefit-risk Estimation