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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

WeekSorted ascending Session Date Topic Reading (PS) Other reading Homework/Exam
  2 1/9 (Th) Clinical trial terminologies and clinical trial phases 2.1 - 2.2, 6.1 - 6.3    
  4 1/16 (Th) Bayesian approaches 5.3 - 5.6    
  6 1/23 (Th) Randomization and masking/blinding 13.1 - 13.9    
  8 1/30 (Th) Sample size and power 1 11.1 - 11.5    
  10 2/6 (Th) Phase I clinical trials 1 10.1 - 10.3    
  12 2/13 (Th) ECMO and TGN1412      
  13 2/20 (Th) Phase II clinical trial     Midterm exam due 2/25
  15 2/27 (Th)        
  - 3/6 (Th) No class Spring break      
      Schedule adjustment Topics: Phase III clinical trials (group sequential and adaptive designs); Meta-analysis; IRB; Misconduct and fraud;    
  17 3/13 (Th) Phase III clinical trial      
  - 3/20 (Th) No class      
  20 3/27 (Th) Phase III clinical trials      
  22 4/3 (Th) Guest Rafe Donahue, PhD    
  24 4/10 (Th) Crossover designs 20.1 - 20.5    
  26 4/17 (Th) Fraud and Misconduct     Final exam due 4/22
1 1 1/7 (Tu) Experimental studies and observational studies      
2 3 1/14 (Tu) Topics in hypothesis testing 5.1 - 5.2    
3 5 1/21 (Tu) schedule adjustment      
4 7 1/28 (Tu) Randomization in clinical trials      
5 9 2/4 (Tu) Sample size and power 2 11.6 - 11.7    
6 11 2/11 (Tu) Phase I clinical trials 2 10.4 - 10.7    
7 - 2/18 (Tu) No class Brad Calin short course      
8 14 2/25 (Tu) Guest Ben Saville, PhD    
9 - 3/4 (Tu) No class Spring break      
10 16 3/11 (Tu) Phase II clinical trial      
11 18 3/18 (Tu) Group Sequential Designs      
12 19 3/25 (Tu) Phase III clinical trial      
13 21 4/1 (Tu) Factorial designs 19.1 - 19.7    
14 23 4/6 (Tu) Factorial designs      
15 25 4/15 (Tu) Crossover designs      
16 27 4/22 (Tu)        

-- TatsukiKoyama - 06 Jan 2013
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Topic revision: r12 - 25 Aug 2015, RobertGreevy
 

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