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Course Catalog

340.645.01 INTRODUCTION TO CLINICAL TRIALS

Department: Epidemiology
Term: 2nd term
Credits: 3 credits
Contact: Janet Holbrook
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 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 Objective(s):
Upon successfully completing this course, students will be able to:
Present the scientific rationale for conducting clinical trials
Assess various clinical trial designs
Discuss randomization and the principle of analysis by assigned treatment
Discuss ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
Illustrate topics with examples of clinical trials

Methods of Assessment: assignments and final exam
Location: East Baltimore
Class Times:
  • Monday 1:30 - 2:20
  • Wednesday 1:30 - 2:20
  • Friday 1:30 - 2:20
Enrollment Minimum: 15
Enrollment Maximum: 75
Instructor Consent: Consent required for all students

If auditing if prerequisite not met

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

340.601 or 340.751

Auditors Allowed: Yes, with instructor consent
Grading Restriction: Letter Grade or Pass/Fail