1University of Florida College of Public Health and Health Professions and College of Medicine PHC 6020: Clinical Trials Methods Fall 2011 Primary Instructor:Xiaomin Lu, Ph.D. Assistant Professor, Department of Biostatistics College of Public Health and Health Professions College of Medicine University of Florida, P.O. Box 117450 Gainesville, FL 32610 352-294-1940 (office); 352-294-1930 (fax); Email: [email protected]Office: Dauer Hall 455 Office hours: TBA Teaching Assistant:TBA Class Schedule:Tuesday 1:55 – 3:50pm @ Little Hall 0203 Thursday 1:55 – 2:45pm @ Turlington Hall 2306Course Webpage:http://users.phhp.ufl.edu/xlu2/Fall11phc6020.htmCOURSE DESCRIPTION AND GOALS This course will introduce some basic statistical concepts and methods used in Epidemiology and will focus on the statistical principles and methods used in clinical trials, including designs and analysis methods in phase I to IV clinical trials. Although the class will have emphasis on phase III trials, we will also discuss the feature and statistical issues in phase I and II clinical trials. For phase III trials, we will discuss ways of treatment allocation that will ensure valid inference on treatment comparison. Other topics include sample size calculation, survival analysis and early stopping of a clinical trial and noncompliance. COURSE MATERIALSReference Textbook: The course will be based primarily on lecture notes that will be handed out periodically in class and available on the course website. Texts that you may wish to consult for further reading are: Steven Piantadosi (2005) Clinical Trials: A Methodologic Perspective, Wiley-Interscience, 2nd edition
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