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---++++ BIOS 6321: Clinical trials and experimental design (Spring 2019)

---+++++ For students only
   * [[CourseBios6321Materials2019][Restricted access]]

---+++++ Instructor
   * [[TatsukiKoyama][Tatsuki Koyama]], !PhD, Associate professor of biostatistics
   * tatsuki.koyama@vumc.org; PRB 582; 615.936.1232
   * Office hours: Thursday 3:00 ~ 4:00 (CQS office in 2525 WEA)

---+++++ Teaching Assistant
   * [[https://www.vanderbilt.edu/biostatistics-graduate/cpt/people/sarah-lotspeich/][Sarah Lotspeich]]
   * sarah.c.lotspeich@vanderbilt.edu 
   * Office hours: Monday: 3:30 ~ 4:30

---+++++ Schedule
   * Lectures: Tuesday and Thursday 1:30-3:00, 2525 Conference Room #11105
   * Midterm exam: 2/21 ~ 2/26
   * Final exam: To be announced.

---+++++ Course description

This course covers the *statistical/mathematical 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, blinding, randomization and balance, blocking, study designs, sample size, interim monitoring of accumulating results, flexible and adaptive designs, and sequential analysis and adjustment techniques. <!--, history of clinical trials, and ethics of animal and human subject experimentation.-->

---+++++ Prerequisite

   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*
      * [[CourseBios6311][Bios 6311]] or equivalent
   * Calculus (3+ semesters)
   * Familiarity with R
      * [[CourseBios301][Bios 6301]]

---+++++ Recommended materials

The lectures will loosely follow "Statistical Design and Analysis of Clinical Trials: Principles and Methods" by Weichung Joe Shih and Joseph Aisner.<br />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, <nop>DeMets DL  

---+++++ Assignments

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

---+++++ Exams

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.

---+++++ 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.  

---++++ Topics
   1 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)
   1 Some fundamental topics in experimental design
      * Randomization (2 lectures)
      * Sample size and power (2 lectures)
   1 Early phase clinical trials
      * Phase I clinical trials (1 lecture)
         * Class discussion (1 lecture)
      * Phase II clinical trials (2 lectures)
   1 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)
   1 Other topics
      * Fraud and misconduct
      * Quality of life
      * Noninferiority designs

%EDITTABLE{ format="|text, 4 |text, 10|textarea, 3*60|textarea, 3*60|"}%
| *Week* | *Date* | *Topics* | *Note* |
| 1 | 1/8/19 | Experiments and observational studies | |
| | 1/10/19 | Topics in hypothesis testing | |
| 2 | 1/15/19 | Topics in hypothesis testing | |
| | 1/17/19 | Bayesian Analysis | |
| 3 | 1/22/19 | Randomization | Homework 1 due |
| | 1/24/19 | Randomization | |
| 4 | 1/29/19 | Sample size and power | Homework 2 due |
| | 1/31/19 | Sample size and power | |
| 5 | 2/5/19 | Sample size and power | Homework 3 due |
| | 2/7/19 | Phase I clinical trials | |
| 6 | 2/12/19 | Phase I clinical trials | Homework 4 due |
| | 2/14/19 | Phase I clinical trials | |
| 7 | 2/19/19 | Phase II clinical trials | Homework 5 due |
| | 2/21/19 | Phase II clinical trials | |
| 8 | 2/26/19 | Non-inferiority trials | Midterm exam due |
| | 2/28/19 | Exam review | |
| 9 | 3/6/19 | -- -- -- -- | Spring break |
| | 3/8/19 | -- -- -- -- | Spring break |
| 10 | 3/12/19 | Meta analysis | |
| | 3/14/19 | Treatment effects monitoring | Homework 6 due |
| 11 | 3/19/19 | Group sequential design | |
| | 3/21/19 | Group sequential design | |
| 12 | 3/26/19 | General adaptive design | |
| | 3/28/19 | General adaptive design | Homework 7 due |
| 13 | 4/2/19 | Multiplicity control? | |
| | 4/4/19 | Guest speaker (Dr. Rafe Donahue) | |
| 14 | 4/9/19 | Factorial design | |
| | 4/11/19 | Factorial design | |
| 15 | 4/16/19 | Cross-over design | |
| | 4/18/19 | Cross-over design | |
| 16 | 4/23/19 | | Final exam due |

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Topic revision: r16 - 21 Mar 2019, TatsukiKoyama

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