Skip to main content

340.645.81
Introduction to Clinical Trials

Course Status
Cancelled

Location
Internet
Term
3rd Term
Department
Epidemiology
Credit(s)
3
Academic Year
2014 - 2015
Instruction Method
TBD
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Prerequisite

Acceptance into the FDA COHORT

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
Enrollment Restriction
Restricted to FDA Fellows in approved program
Special Comments

The third term course is restricted to and offered only to students preselected into a special program limited to Food and Drug Administration employees. No one else is permitted to take this section of this course. There are no exceptions granted.