340.645.81
Introduction to Clinical Trials

Location
Internet
Term
2nd Term
Department
Epidemiology
Credit(s)
3
Academic Year
2024 - 2025
Instruction Method
Asynchronous Online
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Janet Holbrook
Contact Name
Janet Holbrook
Frequency Schedule
Every Year
Prerequisite

Introduction to Online Learning and one of the following: 340.601, 340.721 or 340.751.

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. Includes topics: 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
This course is evaluated as follows:
  • 50% Homework
  • 40% Final Exam
  • 10% Participation
Instructor Consent
No consent required
Special Comments

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