340.635.11
Clinical Trials: Issues and Controversies
Location
East Baltimore
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2013 - 2014
Instruction Method
TBD
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
Resources
Prerequisite
Basic epidemiology.
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.