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BIOS 321: Clinical trials and experimental design (Spring 2013)

For students only

Instructor

Teaching Assistant

Schedule
  • Lectures: Tuesday and Thursday 1:30-3:00, Room RLH 306A/B (Light Hall) [RLH433 on 2/26]

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

Week Session Date Theme Topic Reading (PS)Sorted ascending Other reading Homework
1 1 1/8 (Tu) Introduction Experimental studies and Observational studies      
5 9 2/05 (Tu) schedule updated        
  10 2/07 (Th) schedule updated      
7 13 2/19 (Tu) Phase II clinical trials Overview and basic approaches   Simon (1989)
Koyama (2006) 		 
9 - 3/05 (Tu) Spring break        
  - 3/07 (Th) Spring break        
10 17 3/12 (Tu)   Crossover designs (cont.)   ICH Guidelines E9  
  20 3/21 (Th)   Group-sequential designs   FDA (2010). _Guidance for industry: Adaptive design clinical trials for drugs and biologics_  
12 21 3/26 (Tu) Advanced topics in phase III clinical trials Adaptive designs for Phase III clinical trials   Adaptive designs in clinical drug development - An executive summary of the PhRMA working group  
  22 3/28 (Th)   Adaptive designs for Phase III clinical trials      
14 26 4/9 (Tu) Other experimental designs Case-control studies
Case-cohort studies
Nested case-control studies 		     
15 27 4/16 (Tu) Open        
  28 4/18 (Th) Final exam due        
  2 1/10 (Th)   Introduction to clinical trials
Terminology
Clinical trial phases 		2.1 - 2.2
6.1 - 6.3 		   
13 24 4/02 (Tu) Ethics in clinical trials IRB, consent 3.1 - 3.8 ICH Guidelines E6 Sections 1-5  
2 3 1/15 (Tu) Statistics Statistics review 1
Frequentist perspectives 		5.1 - 5.2    
  4 1/17 (Th)   Statistics review 2
Bayesian perspectives 		5.3 - 5.6 Points to consider on switching between superiority and non-inferiority

(http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf) 		 
6 11 2/12 (Tu) Phase I clinical trials Overview and frequentist approaches 10.1 - 10.3    
  12 2/14 (Th)   Bayesian approaches 10.4 - 10.7    
4 7 1/29 (Tu) Sample size and power Simple situations 11.1 - 11.5    
  8 1/31 (Th)   More complex situations 11.6 - 11.7    
3 5 1/22 (Tu) Randomization Randomization and masking 13.1 - 13.9    
  6 1/24 (Th)   Randomization in clinical trials 13.1 - 13.9    
11 19 3/19 (Tu) Phase III clinical trials Fundamentals of Treatment Effects Monitoring 14.1 - 14.6    
  23 4/11 (Th)   Reporting and Authorship 18.1 - 18.7    
8 15 2/26 (Tu)   Factorial designs 19.1 - 19.7    
  16 2/28 (Th)   Crossover designs 20.1 - 20.5    
  18 3/14 (Th)   Meta analysis 21.1 - 21.5    
  25 4/04 (Th)   Misconduct and fraud 22.1 - 22.8 Declaration of Helsinki (Appendix E)  
  14 2/21 (Th) Phase II clinical trials
Midterm exam (due 2/26) 		Advanced topics in Phase II clinical trials Midterm up to phase II clinical trials    

-- TatsukiKoyama - 06 Jan 2013
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