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- Tatsuki Koyama, PhD, Associate professor of biostatistics
- tatsuki.koyama@vanderbilt.edu; PRB 582; 615.936.1232
- Office hours: Thursday 3-4 in 11128A WEA

- Jonathan Chipman, PhD Candidate
- jonathan.chipman@vanderbilt.edu
- Office hours: Friday 1:30-2:30 where?

- Lectures: Tuesday and Thursday 1:30-3:00, 2525 Conference Room #11105
- Midterm exam: 2/27/18 (due)
- Final exam: 4/24/18 (due)

If you are not a graduate student in the Department of Biostatistics, please email me to confirm you have sufficient math background to take this course.

- At least one semester of graduate level statistics
- Bios 6311 or equivalent

- Calculus (3+ semesters)
- Familiarity with R

Other good books: "Introduction to Statistical Methods for Clinical Trials" by Thomas D. Cook and David L. DeMets; ''Fundamentals of clinical trials (4th ed)'' by Friedman LM, Furberg CD, DeMets DL

There will be homework assignments throughout the semester. Collaboration with classmates is encouraged, but you need to submit homework individually.

The midterm and final exams will be take-home. You will have a weekend (Thursday - Tuesday) to work on them. You are to work by yourself; no discussion is allowed.

- Homework and project (and class participation): 30%
- Midterm Exam (Take home): 35%
- Final Exam (Take home): 35%

- Introduction and topics in statistics
- Experiments and observational studies (1 lecture)
- Clinical trial phases (1 lecture)
- Topics in hypothesis testing (2 lectures)
- Bayesian approaches (1 lecture)

- Some fundamental topics in experimental design
- Randomization (2 lectures)
- Sample size and power (2 lectures)

- Early phase clinical trials
- Phase I clinical trials (1 lecture)
- Class discussion (1 lecture)

- Phase II clinical trials (2 lectures)

- Phase I clinical trials (1 lecture)
- Phase III clinical trials
- Introduction and group sequential designs (2 lectures)
- Adaptive and flexible designs (2 lectures)
- Guest lecturer (1 lecture)

- Factorial designs (2 lectures)
- Crossover designs (2 lectures)

- Other topics
- Fraud and misconduct
- Quality of life
- Noninferiority designs

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