Clinical Trial Outcomes: Measurement, Analysis, and Interpretation

This course is intended to teach students the skills necessary to select and/or design appropriate outcomes for a clinical trial. Students will focus on recent changes in our understanding of clinical trial outcome measurements, analyses, and interpretation for both subjective and objective phenomena, such as adherence, use of multiple outcomes, and clinical importance. While design issues for clinical trials are the main focus, other types of clinical studies will be considered as appropriate. Students will be expected to learn about the problems inherent in the design of outcome measures of health and how to apply different epidemiologic and biostatistical concepts toward a solution. It is expected that at the conclusion of the course, students will be able to plan a clinical trial with a valid, responsive and interpretable outcome. The class will meet once weekly for a 60-minute lecture on a topic, followed by a 60- to 90-minute discussion of how that topic applies to the specific issues of interest to the students or the instructor.