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Course Catalog

340.645.01 INTRODUCTION TO CLINICAL TRIALS

Department:
Epidemiology
Term:
2nd term
Credits:
3 credits
Academic Year:
2014 - 2015
Location:
East Baltimore
Class Times:
  • M W F,  1:30 - 2:20pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Janet Holbrook
Course Instructors:

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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 I-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; data analysis principles; monitoring of accumulating safety and efficacy data; and use of data from randomized trials.

Learning Objectives:

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

  1. Present the scientific rationale for conducting clinical trials
  2. Assess various clinical trial designs
  3. Discuss randomization and the principle of analysis by assigned treatment
  4. Discuss ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
  5. Illustrate topics with examples of clinical trials
Methods of Assessment:
Exercises – 50% (10%, or 10 points, for each exercise);
Final exam – 40%;
Participation –10%
Instructor Consent:
Consent required for all students
Consent Note:

If auditing if prerequisite not met

For consent, contact:
jholbroo@jhsph.edu
Prerequisite:

340.601 or 340.751