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Design and Conduct of Clinical Trials

Winter Institute
Academic Year
2023 - 2024
Instruction Method
Synchronous Online
Start Date
Monday, January 15, 2024
End Date
Friday, January 19, 2024
Class Time(s)
M, Tu, W, Th, F, 8:30 - 11:50am
Auditors Allowed
Available to Undergraduate
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Next Offered
2023 - 2024


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 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. Understand the scientific rationale for conducting randomized trials
  2. Become familiar with various trial designs
  3. Understand randomization and the principle of analysis by assigned treatment
  4. Be 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
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.