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---++++ BIOS 6321: Clinical trials and experimental design (Spring 2017)

---+++++ For students only
   * [[CourseBios6321Materials2017][Restricted access]]

---+++++ Instructor
   * Tatsuki Koyama, !PhD, Associate professor of biostatistics
   * tatsuki.koyama@vanderbilt.edu; PRB 582; 615.936.1232
   * Office hours: Thursday 3-4

---+++++ Teaching Assistant
   * Molly Olson
   * molly.a.olson@vanderbilt.edu
   * Office hours: Monday 11-12 & Friday 2-3.

---+++++ Schedule
   * Lectures: Tuesday and Thursday 1:30-3:00, 2525 Conference Room #11105   
   * Midterm exam: 2/28/17 (due)
   * Final exam: 4/25/17 (due)


---+++++ Course description
This course covers the <b>statistical aspects</b> 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, sequential analysis and adjustment techniques, history of clinical trials, and ethics of animal and human subject experimentation.

---+++++ Prerequisite
   * 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 "Introduction to Statistical Methods for Clinical Trials" by Thomas D. Cook and David L. !DeMets.<br>Other good book: ''Fundamentals of clinical trials (4th ed)'' by Friedman LM, Furberg CD, <nop>DeMets</nop> 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): [1.3]
      * 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): [3.1.1]
         * Class discussion (1 lecture)
      * Phase II clinical trials (2 lectures): [3.1.2]
   1 Phase III clinical trials: [3.2]
      * Introduction and group sequential designs (2 lectures)
      * Adaptive and flexible designs (2 lectures): [10.4, 10.7, 3.5]
         * Guest lecturer (1 lecture)
      * Factorial designs (2 lectures): [3.2.2]
      * Crossover designs (2 lectures): [3.2.2]
   1 Other topics 
      * Fraud and misconduct
      * Quality of life
      * Noninferiority designs: [3.3]

%EDITTABLE{ format="|text, 4 |text, 10|textarea, 3*60|textarea, 3*60|"}% 
| *Week* | *Date* | *Topics* | *Note* |
| 1 | 1/10/17 | Experiments and observational studies | |
| | 1/12/17 | Topics in hypothesis testing | |
| 2 | 1/17/17 | Topics in hypothesis testing<br />Clinical trial phases<br />Bayesian analysis | |
| | 1/19/17 | Bayesian analysis<br />Randomization | |
| 3 | 1/24/17 | Randomization | |
| | 1/26/17 | Randomization<br />Sample size and power | |
| 4 | 1/31/17 | Sample size and power | |
| | 2/2/17 | Sample size and power<br />Phase I clinical trials | |
| 5 | 2/7/17 | Phase I clinical trials | |
| | 2/9/17 | Phase I clinical trials | |
| 6 | 2/14/17 | Phase II clinical trials | |
| | 2/16/17 | Phase II clinical trials | |
| 7 | 2/21/17 | Non-inferiority | |
| | 2/23/17 | -- -- -- -- | No class |
| 8 | 2/28/17 | Group sequential design | Midterm exam due |
| | 3/2/17 | Group sequential design | |
| 9 | 3/7/17 | -- -- -- -- | Spring break |
| | 3/9/17 | -- -- -- -- | Spring break |
| 10 | 3/14/17 | Factorial design | |
| | 3/16/17 | Topics in regression analysis | |
| 11 | 3/21/17 | Crossover design | |
| | 3/23/17 | Crossover designs | |
| 12 | 3/28/17 | Meta analysis | |
| | 3/30/17 | -- -- -- -- | No Class |
| 13 | 4/4/17 | Dr. Lorraine Ware | |
| | 4/6/17 | Dr. Rafe Donahue | |
| 14 | 4/11/17 | Treatment Effect Monitoring | |
| | 4/13/17 | Adaptive designs | |
| 15 | 4/18/17 | Adaptive designs | |
| | 4/20/17 | Fraud and misconduct | |
| 16 | 4/25/17 | | Final exam due |
| | 4/27/17 | -- -- -- -- | |
| 17 | 5/2/17 | -- -- -- -- | Finals week |
| | 5/4/17 | -- -- -- -- | Finals week |

Topic revision: r17 - 16 Apr 2017, TatsukiKoyama

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