QBS 138 Clinical Trials
Clinical trials constitute the frontline approach for evaluating safety, efficacy, and side effect profiles of biomedical interventions. The purpose of this course is to provide students a basic understanding of research design and methodology, including sampling methods, sources of error, selection and operationalization of variables, requirements for causality, and internal and external validity. Students will gain exposure to a range of clinical trial designs and their applications, including open/uncontrolled trials, multi-arm randomized controlled trials and their variants, adaptive trials, precision medicine trial designs, and hybrid effectiveness-implementation designs. A special emphasis will be placed on methods for statistical analysis of clinical trial results and power analysis as it applies to determining sample size in clinical trials. Students will also gain insight into methodological challenges in clinical trial design across diseases and settings. All class meetings will include relevant reading from the published biomedical literature.
(1 unit)
Instructor
Dr. Emily Presseller
Cross Listed Courses
HSE 138