340.613.11
Design and Conduct of Clinical Trials

Location
East Baltimore
Note: Due to the COVID-19 Pandemic, this course was held in a virtual/online format.
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2021 - 2022
Instruction Method
In-person
Start Date
Monday, June 14, 2021
End Date
Friday, June 18, 2021
Class Time(s)
M, Tu, W, Th, F, 1:30 - 4:50pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
David Shade
Elizabeth Sugar
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: 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
Instructor Consent
No consent required
Special Comments

Course will taught online via Zoom, on the dates and times the course is scheduled. For further information, please see the Institute website jhsph.edu/summerepi