Design and Conduct of Clinical Trials
June 13-17, 2016
8:30 a.m. – 12:00 p.m.
Course Number: 340.613.11
For those wanting to become acquainted with basic clinical trial methodology, either to broaden their knowledge of public health and clinical research, or to obtain a basis for more advanced study of the design and conduct of clinical trials.
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.
Student Evaluation: Student evaluation is based upon group work and an examination.
- Present the scientific rationale for conducting randomized trials
- Acquaint students with various trial designs
- Provide an understanding of randomization and of the principle of analysis by assigned treatment
- Familiarize students with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
- Illustrate topics with examples of clinical trials.
Prerequisite: 340.601 or equivalent work experience
Grading Options: Letter Grade or Pass/Fail
Course Materials: Provided in class and through CoursePlus