340.613.13
Design and Conduct of Clinical Trials

Cancelled

Location
East Baltimore
Term
Winter Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2024 - 2025
Instruction Method
TBD
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
David Shade
Contact Name
Ayesha Khan
Frequency Schedule
Every Year
Prerequisite

340.601

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 such as the definition and history of clinical trials; trial designs, including phase III-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; introductions to data collection and management and analysis principles; monitoring of trials for safety and efficacy; and use of clinical trial data in healthcare decision-making.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Identify the scientific rationale for conducting randomized trials
  2. Become familiar with various trial designs
  3. Identify randomization and the principle of analysis by assigned treatment
  4. Become familiar with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
Methods of Assessment
This course is evaluated as follows:
  • 40% Group Work
  • 60% Final Exam
Instructor Consent
No consent required
Special Comments

The course will be taught online via Zoom, on the dates and times the course is scheduled. For further information, please see the Institute website.