Biostat 615
Design and Analysis of Clinical Trials
Autumn 2008
Instructor: Professor Jason Hsu
Office: 204D Cockins Hall
e-mail: Hsu.1@osu.edu
Phone: 292-7663
Office Hours: Thursday 2:30 to 3:30
Syllabus (this page):
http://www.stat.ohio-state.edu/~jch/615/615syllabus.html
Homework page: http://www.stat.ohio-state.edu/~jch/615/615homework.html
TA: Siyoen Kil
Office Hours: Tuesday Thursday 11:00 to 1:00
Office: CH 320
Phone: 614-292-7538
e-mail: siyoen@stat.osu.edu
Text: Class notes
References:
- ICH Guidances E4, E9, and E10.
- Piantadosi, Steven (1997). Clinical Trials: A Methodologic
Perspective. Wiley.
- Senn, Stephen (1997). Statistical Issues in Drug Development.
Wiley.
- Pocock, Stuart J. (1983). Clinical Trials: A Practical
Approach. Wiley.
- Chow, Shein-Chung and Jen-Pei Liu (1992). Design and Analysis
of Bioavailability and Bioequivalence Studies. Marcel Dekker.
- Fleiss, Joseph L. (1986). The Design and Analysis of Clinical
Experiments. Wiley.
List of Topics
- Statistics in Confirmatory Studies
- Making statistical decision in pharmaceutics
- Scientific background
- Formulating a decision problem statistically
- Formulating null hypotheses properly
- Decision-making based on confidence sets
- p-values versus confidence sets
- Concepts of Error Rates
- Bioequivalence: An Example of Pharmacokinetics
- Significant difference vs. practical equivalence trials
- Average bioequivalence
- Population and individual bioequivalence
- Dose-response Studies
- Choice of control groups
- The therapeutic window
- Inference on the Minimum Effective Dose (MED)
- Union-Intersection Testing
- Closed testing - steps sample-determined
- Partitioning - steps sample-determined
- Partitioning - steps pre-determined
- Pivotal Trials
- Primary and secondary endpoints
- Inference on multiple endpoints
- Pharmacogenomics
Grading:
Homework 35%
Midterm Thursday 10/30/08 10:30 AM - 11:30 AM 30%
Final Monday 12/08/08 9:30 - 11:18 AM 35% (note: date posted earlier
was incorrect)