Adaptive and Flexible Clinical Trials

ISBN-13: 9780367382476 / Angielski / Miękka / 2019 / 198 str.

Richard Chin

Opis

By enabling studies to be modified during the course of the trial, modern adaptive clinical trial designs can make studies substantially faster, more efficient, and more powerful than traditional clinical trials. The recent advances in web-based real-time data entry and novel statistical methods have made adaptive clinical trials practical and attractive. Suitable for readers involved in drug development, this is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Without using highly technical statistical jargon, it discusses the design, conduct, and execution of these trials.

Spis treści

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.

O autorze

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.