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340.635.11
Clinical Trials: Issues and Controversies

Location
East Baltimore
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2012 - 2013
Instruction Method
TBD
Start Date
Monday, June 25, 2012
End Date
Friday, June 29, 2012
Class Time(s)
M, Tu, W, Th, F, 8:30am - 12:00pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Other Year
Next Offered
2024 - 2025
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. Students will also visit a clinical trials research unit.