Skip Navigation

Course Directory

Introduction to Clinical Trials

2nd term
3 credits
Academic Year:
2019 - 2020
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor :
Janet Holbrook

Introduction to Online Learning and one of the following: 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:

50% homework assignments, 10% class participation and 40% final exam

Instructor Consent:

No consent required

Special Comments:

The course 340.613.11 is a subset of this course and may present duplicate information.