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Introduction to Clinical Trials


East Baltimore
2nd term
3 credits
Academic Year:
2019 - 2020
Class Times:
  • M W F,  1:30 - 2:20pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor s:
Janet Holbrook

340.601, 340.721 or 340.751


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:

assignments and final exam

Instructor Consent:

Consent required for some students

Consent Note:

Please contact instructor only if auditing, or if prerequisite not met

For consent, contact: