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.…mehr
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.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
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.
Inhaltsangabe
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.
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.
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