BIOS 321: Clinical trials and experimental design (Spring 2014)
For students only
Instructor
Teaching Assistant
Schedule
- Lectures: Tuesday and Thursday 1:30-3:00, 2525 Conference Room #11105
Course description
This course covers the statistical aspects of study designs, monitoring and analysis. Emphasis is on studies of human subjects, i.e. clinical trials. Topics include: principles of measurement, selection of endpoints, bias, masking, randomization and balance, blocking, study designs, sample size projections, study conduct, interim monitoring of accumulating results, flexible and adaptive designs, sequential analysis, analysis principles, adjustment techniques, compliance, data and safety monitoring boards (DSMB), Institutional Review Boards (IRB), the ethics of animal and human subject experimentation, history of clinical trials, and the Belmont report.
Prerequisite
Bios 311 or equivalent
Bios 301 or equivalent (familiarity with R)
Familiarity with R: If you did not take Bios 301, check with the instructor.
Textbook and other recommended materials
Required book: ''Clinical trials: a methodologic perspective (2nd ed)'' by Piantadosi S
Recommended book: ''Fundamentals of clinical trials (4th ed)'' by Friedman LM, Furberg CD, DeMets DL
Assignments
There will be homework assignments throughout the semester. You are welcome to discuss the homework assignments with classmates, but you need to submit homework individually.
Grading
- Homework and project (and class participation): 30%
- Midterm Exam (Take home): 35%
- Final Exam (Take home): 35%
The final exam will focus on the post-midterm materials, however, key concepts covered before the midterm may (almost surely) also appear.
Tentative schedule
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TatsukiKoyama - 06 Jan 2013