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340.613.11 DESIGN AND CONDUCT OF CLINICAL TRIALS

Department: Epidemiology
Term: Summer Inst. term
Credits: 2 credits
Contact: Ayesha Khan
Academic Year: 2013 - 2014
Course Instructors:
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 Objective(s):
Upon successfully completing this course, students will be able to:
Understand the scientific rationale for conducting randomized trials
Become familar with with various trial designs
Understand randomization and of the principle of analysis by assigned treatment
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.
Location: East Baltimore
Class Times:
  • Mon 06/17/2013 - Fri 06/21/2013
  • Monday 1:30 - 5:00
  • Tuesday 1:30 - 5:00
  • Wednesday 1:30 - 5:00
  • Thursday 1:30 - 5:00
  • Friday 1:30 - 5:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

340.601

Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail