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Course Catalog

340.635.11 CLINICAL TRIALS: ISSUES AND CONTROVERSIES

Department:
Epidemiology
Term:
Summer Inst. term
Credits:
2 credits
Academic Year:
2013 - 2014
Location:
East Baltimore
Class Times:
  • M Tu W Th F,  8:30am - 12:00pm
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Ayesha Khan
Course Instructor:
Frequency Schedule:
Every Other Year
Next Offered:
2016 - 2017

Course Evaluation

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Prerequisite:

Basic epidemiology.

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.

Methods of Assessment:

5 page paper

Instructor Consent:

No consent required