Advanced Statistical Methods for Clinical Trials
- Course Number
- CHL5225H
- Series
- 5200 (Biostatistics)
- Format
- Lecture
- 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.
Course Objectives
- To understand the traditional and complex trial designs at each phase of clinical development.
- To learn how to use analytical calculations and statistical simulations to evaluate and compare the operating characteristics of competing trial designs.
- To learn about the role of a trial statistician including protocol writing, interim monitoring, analysis, and reporting.
Methods of Assessment
| Participation | 5% |
| Assignments (3 x 10%) | 30% |
| Term Project | 20% |
| Quiz | 15% |
| Final Exam | 30% |