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Zusatztext "For the past few decades! adaptive clinical trials (ACT) have been enjoying increasing popularity and attention in biomedical research and industry ? what was lacking was a 'real' book that would summarize these techniques to a wider audience. Dr. Richard Chin fills this void with his commendable book ? The book is nicely written and lucid! with a proper sequencing of concepts."-Journal of the American Statistical Association! December 2013"? later chapters in the book ? are most useful. They describe the various types of adaptations that can be used. ? This book is helpful for a starter in adaptive designs! to get an idea of the visions behind applying such designs."-Philip Hougaard and Corine Baayen! ISCB Newsletter! June 2013 Informationen zum Autor 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. Klappentext Unlike traditional fixed clinical trials that cannot be altered once the study begins, adaptive designs allow the study design to be modified in response to the data being generated in the course of the trial. The newly developed web-based real-time data entry and recent advances in statistical methods have made it possible to perform real-time, adaptive clinical trials. Suitable for readers in academia, industry, and government involved in drug development, this up-to-date, easy-to-read book covers the essential aspects of adaptive clinical trials. It discusses the design, conduct, and execution of these trials. "... later chapters in the book ... are most useful. They describe the various types of adaptations that can be used. ... This book is helpful for a starter in adaptive designs, to get an idea of the visions behind applying such designs." -Philip Hougaard and Corine Baayen, ISCB Newsletter, June 2013 Zusammenfassung 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 boo...
