340.613.11
Design and Conduct of Clinical Trials
Location
East Baltimore
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2025 - 2026
Instruction Method
In-person
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
340.601
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:
- Identify the scientific rationale for conducting randomized trials
- Become familiar with various trial designs
- Identify randomization and the principle of analysis by assigned treatment
- 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
This is a hybrid course with both an in-person section (340.613.11) and a synchronous online section (340.613.49). Please choose the modality you need (either in-person or online) when registering in SIS.