New Drug Development

Dr. Rick Turner is an experimental research scientist, clinical trialist, and author. He was awarded his doctoral degree in the field of Cardiovascular Behavioral Medicine in 1984. His innovative genetic research in that discipline led to 50 peer-reviewed papers, five books, and two international research awards. Fifteen years ago Dr. Turner moved into the pharmaceutical industry, holding positions as a Clinical Submissions Scientist at GlaxoSmithKline and as President and Chief Scientific Officer at Turner Medical Communications LLC. He is now Senior Scientific Director, Cardiac Safety Services, at Quintiles, the world’s largest pharmaceutical contract research organization. His work focuses on assessing the cardiac safety of non-cardiac drugs. He has spoken before two FDA Advisory Committees on cardiovascular safety issues, given numerous presentations at international conferences, and published several recent peer-reviewed papers in this field. He is also the senior author of 'Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance' (Turner and Durham, 2009).

• New Drug Development.- The Regulatory Environment.- Drug Discovery.- Nonclinical Research.- Designing Clinical Trials.- Conducting Clinical Trials I: Experimental Methodology.- Conducting Clinical Trials II: Operational Execution.- Statistical Analysis.- Statistical Significance.- Clinical Significance.- Sample Size Estimation.- General Safety Assessments.- Efficacy Assessment.- Cardiac and Cardiovascular Safety Assessments.- Manufacturing Small Molecule Drugs and Biologicals.- Postmarketing Surveillance.- Main Themes and Concluding Comments.

From the reviews of the second edition: "'New Drug Development: An Introduction to Clinical Trials, 2nd Edition' is a solid introduction to the process of drug development, with an emphasis on clinical research, especially the statistical aspects. It is ideal for readers interested in clinical research within the broader context. The book is written in a practical and straightforward manner ... ." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 9 (5), May, 2013)