340.635.11 CLINICAL TRIALS: ISSUES AND CONTROVERSIES
June 27-July 1, 2016
8:30 a.m. – 12:00 p.m.
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
- Review core concepts related to the design and conduct of clinical trials
- Discuss selected issues and controversies
- Discuss illustrative trials
Prerequisite: Basic epidemiology.
Auditors Allowed: No
Grading Restriction:Letter Grade or Pass/Fail
Frequency Schedule: Every Other Year