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Course Catalog

340.635.11 CLINICAL TRIALS: ISSUES AND CONTROVERSIES

Department: Epidemiology
Term: Summer Inst. term
Credits: 2 credits
Contact: Ayesha Khan
Academic Year: 2012 - 2013
Course Instructor:
Description:

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. Students will also visit a clinical trials research unit.

Learning Objective(s):


Methods of Assessment: 5 page paper
Location: East Baltimore
Class Times:
  • Mon 06/25/2012 - Fri 06/29/2012
  • Monday 8:30 - 12:00
  • Tuesday 8:30 - 12:00
  • Wednesday 8:30 - 12:00
  • Thursday 8:30 - 12:00
  • Friday 8:30 - 12:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

Basic epidemiology.

Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail
Frequency Schedule: Every Other Year
Next Offered: 2014-2015