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 much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon.
Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.
Table of Contents
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.
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.