1st Edition

Adaptive and Flexible Clinical Trials

By Richard Chin Copyright 2012
198 Pages
by CRC Press

198 Pages
by CRC Press

198 Pages
by CRC Press

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials... Read more

Background. Background: Conventional Statistics. Statistics Used in Adaptive Clinical Trials. Specific Requirements for Adaptive Trials. Adaptive Randomization and Allocation. Sample Size Reestimation. Traditional Dosing. Adaptive Dosing. Interim Analysis and Adaptive Termination of Study and Study Arms. Adaptive Changes in Study Design and Decision Rules. Seamless Designs and Adaptive Clinical Trial Conduct. Analysis and Interpretation of Results. Index.

Biography

Richard Chin, M.D. is the Chief Executive Officer of OneWorld Health, a nonprofit pharmaceutical company largely funded by the Bill and Melinda Gates Foundation, developing drugs for impoverished patients in the developing world.  Previously, Dr. Chin held multiple senior positions in several biotechnology companies and has extensive expertise in drug development including 10 new drug registrations filings/launches and over 45 Investigational New Drug (IND) Applications. Some of the drugs he has overseen include Rituxan, Lucentis, Tysabri, TNKase, Raptiva, Xolair, Cathflo, Prialt, Protropin, Nutropin, Pulmo- zyme, Azactam, Maxipime, and Bapineuzumab, among others. Dr. Chin was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned his M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar. Dr. Chin serves as Associate Professor at UCSF School of Medicine and was previously on the adjunct faculty at Stanford University School of Medicine.