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Course Catalog

340.613.11 DESIGN AND CONDUCT OF CLINICAL TRIALS

Department:
Epidemiology
Term:
Summer Inst. term
Credits:
2 credits
Academic Year:
2013 - 2014
Location:
East Baltimore
Dates:
Mon 06/17/2013 - Fri 06/21/2013
Class Times:
  • M Tu W Th F,  1:30 - 5:00pm
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Ayesha Khan
Course Instructors:

Course Evaluation

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Prerequisite:

340.601

Description:

Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase III-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; introductions to data collection and management and analysis principles; monitoring of trials for safety and efficacy; and use of clinical trial data in healthcare decision-making.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Understand the scientific rationale for conducting randomized trials
  2. Become familar with with various trial designs
  3. Understand randomization and of the principle of analysis by assigned treatment
  4. Be familiar with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
Methods of Assessment:

Student evaluation is based upon group work and an examination.

Instructor Consent:

No consent required