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Course Catalog

340.645.81 Introduction to Clinical Trials

1st term
3 credits
Academic Year:
2014 - 2015
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Janet Holbrook
Course Instructors:

Introduction to Online Learning plus 340.751 or 340.601.


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 adverse event reporting.

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 50% (10% for each exercise); Final Exam 40%, Participation 10%

Instructor Consent:

No consent required