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Introduction to Statistical Methods for Clinical Trials

Course Number
5200 (Biostatistics)
Course Instructor(s)
Wendy Lou, Clement Ma

Course Description

The fundamentals of planning and analysis of clinical trials are an integral part of biostatistician’s training. At the end of the course, the students should be able to critically evaluate plans and designs for clinical trials, participate in protocol writing, help to formulate a primary research question/hypothesis that can be statistically tested in a trial, help to specify appropriate intervention and control groups and outcomes, use available design and analysis options to reduce bias and variability of the results, and determine the size of a trial to obtain appropriate power to detect differences. The students will also have familiarity with the statistical aspects of the CIHR RCT evaluation criteria and structure (

Methods of Assessment

Participation 10%
Assignments (4 x 10% each) 40%
Midterm 20%
Final Exam 30%