StudentOutline - Dalla Lana School of Public Health,...

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Dalla Lana School of Public Health, University of Toronto CHL 5225 H – Advanced Statistical Methods for Clinical Trials Website: Instructors Melania Pintilie Princess Margaret Hospital, 610 University Ave. Rm. 10-510 (416) 946-4501 * 16-4886 [email protected] Greg Pond Henderson Hospital 711 Concession Street 60 (G) Wing, 1st Floor Hamilton Ontario, L8V 1C3 (905) 527-2299 * 42616 [email protected] Janet Raboud 60 Murray Street, Room 5-244 (416) 586-8852 [email protected] Kevin Thorpe 80 Bond Street and HSB 649 (416) 864-5776 [email protected] Andrew Willan (coordinator) 123 Edward Street, Room 404 (416) 813-2166 [email protected] 1) Overview: Academic and professional statisticians are frequently included as co-investigators on clinical trials. Their responsibilities as a co-investigator usually include trials design, involving issues of randomization, stratification and sample size determination, as well as statistical data analysis, reporting and presentation. Consequently, there is substantial demand from academia and the pharmaceutical industry for graduate level statisticians with training and experience in advanced statistical methodology for clinical trial. In response to that demand this course has been designed to provide exposure to the advanced statistical methods used in clinical trials for students seeking graduate degrees in biostatistics or statistics. The intended student population is meant to be graduate students in biostatistics and statistics.
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2) Teaching objectives: a) To gain an understanding of language and methodology of clinical trials. b) To gain proficiency in advanced statistical methods in the design of clinical trials. c) To gain proficiency in advanced statistical methods in the analysis of clinical trials. 3) Course prerequisites: Bachelor’s degree in biostatistics or statistics or the equivalent, and a thorough understanding of mathematical statistics, calculus and matrix algebra. 4) Format of instruction: There will be 3 hours of lectures each week. There will be three homework data sets. Each data set will include methodological and computational exercises. Each student will also work on an individual project for classroom presentation. The presentation project can be the presentation of (i) a recent statistical methodology paper pertaining to clinical trials, (ii) an interesting statistical methodology issue in a recently published report of a clinical trial or (iii) the presentation of the analysis of data from a real (non-trivial) clinical trial. The topic for each project must be approved by the a course instructor. A written report of the presentation project is also required 4.1 Role of data sets: The only way to learn new statistical methods is to perform them on real or realistic data sets. Therefore, analyzing homework data sets is crucial to mastering these methods. The data sets will attempt to expose students to the typical issues that arise when analyzing clinical trials data. 4.2 Computing:
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This note was uploaded on 02/23/2012 for the course CHL 5225H taught by Professor Andrewwillian during the Fall '12 term at University of Toronto- Toronto.

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StudentOutline - Dalla Lana School of Public Health,...

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