340.647.01
Advanced Topics in Clinical Trials
Location
East Baltimore
Term
4th Term
Department
Epidemiology
Credit(s)
3
Academic Year
2025 - 2026
Instruction Method
In-person
M, W, 1:30 - 2:50pm
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
Yes
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
Intro to clinical Trials 340.645 or 340.613.
Enrollment Restriction
This course is not restricted.
Learn more than the basics needed to design and implement real-world clinical trials.
Builds on introductory materials in clinical trials by elaborating on advanced topics in trial design, operations, and analysis. Introduces advanced designs, budgeting and recruitment strategies, data collection and management, communication of results, and reporting responsibilities. Teaches financial and administrative aspects of trial planning, the design of data collection instruments, randomization procedures, recruitment approaches, trial regulatory submissions, the roles and responsibilities of a data/clinical coordinating center, and methods for the communication and interpretation of trial results.
Learning Objectives
Upon successfully completing this course, students will be able to:
- Compare and contrast important points for common trial designs, including parallel group, group sequential, and simulated trials
- Compare and contrast design elements for less common trial designs, such as platform and single-arm studies
- Create high-quality data collection instruments
- Help develop modern data-entry and data management systems
- Describe the tasks involved in the design and implementation of study websites and study drug distribution systems
- Discuss ethical and regulatory considerations in trial design and conduct
Upon successfully completing this course, students will be able to:
Methods of Assessment
This course is evaluated as follows:
- 10% Participation
- 50% Assignments
- 20% Group Project(s)
- 20% Final Exam
Course combines 340.633 and 340.655. Students who have completed either course, should not take this course.