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Graduate Summer Institute of Epidemiology and Biostatistics


June 27-July 1, 2016
8:30 a.m. – 12:00 p.m.
2 credits

Course Instructor



Covers the complex issues and controversies that surround the design, analysis and interpretation of clinical trials. Topics include selection of the study population (including issues related to enrollment of minorities and women); choice of "control" and "active" treatments including use of placebos; issues pertaining to informed consent; use of intermediate (or pre-clinical) outcomes versus clinical outcomes; adaptive designs; pragmatic vs. explanatory trials; comparative effectiveness research and the role of trials; and issues related to publication and dissemination. Uses examples of published, on-going and planned studies. 

Course Syllabus

Methods of Assessment: 5 page paper

Learning Objectives:

  • Review core concepts related to the design and conduct of clinical trials
  • Discuss selected issues and controversies
  • Discuss illustrative trials

Instructor Consent: No consent required

Prerequisite: Basic epidemiology.

Auditors Allowed: No

Grading Restriction:Letter Grade or Pass/Fail

Frequency Schedule: Every Other Year