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Department: Epidemiology
Term: 3rd term
Credits: 3 credits
Contact: Janet Holbrook
Academic Year: 2012 - 2013
Course Instructors:

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):

Present the scientific rationale for conducting clinical trials • Acquaint students with various clinical trial designs • Provide an understanding of randomization and of the principle of analysis by assigned treatment • Familiarize students with 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: Internet
Enrollment Minimum: 3
Enrollment Maximum: 50
Enrollment Restriction: Restricted to FDA Fellows in approved program
Instructor Consent: Consent required for all students

Consent of instructor is required.

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