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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:

  1. Review core concepts related to the design and conduct of clinical trials
  2. Discuss selected issues and controversies
  3. Discuss illustrative trials
Methods of Assessment:

short paper 100%

Instructor Consent:

No consent required