340.613.11
Design and Conduct of Clinical Trials
- Location:
- East Baltimore
- Term:
- Summer Inst. term
- Department:
- Epidemiology
- Credits:
- 2 credits
- Academic Year:
- 2022 - 2023
- Instruction Method:
- Hybrid In-person and Synchronous Online
- Dates:
- Mon 06/13/2022 - Fri 06/17/2022
- Class Times:
-
- M Tu W Th F, 1:30 - 5:00pm
- Auditors Allowed:
- No
- Grading Restriction:
- Letter Grade or Pass/Fail
- Course Instructors:
- Contact:
- Ayesha Khan
- Resources:
- Prerequisite:
- 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. 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:
- Understand the scientific rationale for conducting randomized trials
- Become familiar with various trial designs
- Understand randomization and the principle of analysis by assigned treatment
- 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:
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.