340.635.11
Clinical Trials: Issues and Controversies
Discontinued
- Location:
- East Baltimore
- Term:
- Summer Inst. term
- Department:
- Epidemiology
- Credits:
- 2 credits
- Academic Year:
- 2020 - 2021
- Instruction Method:
- TBD
- Auditors Allowed:
- No
- Grading Restriction:
- Letter Grade or Pass/Fail
- Course Instructor:
- Contact:
- Ayesha Khan
- Frequency Schedule:
- Every Other Year
- Resources:
- 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.
- Learning Objectives:
-
Upon successfully completing this course, students will be able to:
- Review core concepts related to the design and conduct of clinical trials
- Discuss selected issues and controversies
- Discuss illustrative trials
- Methods of Assessment:
short paper 100%
- Instructor Consent:
No consent required