This is an overview course in clinical trial methodology, focusing primarily on designs of clinical drug trials and non-clinical research experiments intended to answer clinical questions. In addition to a comprehensive review of study design elements and their advantages and disadvantages of commonly used study designs, frequently observed flaws in study design will be presented both in the lectures, and through reviews of published papers. Another objective of this course is to show the integration of (or interrelationship between) experimental design choices and their impact on subsequent trial size, duration, and statistical analysis. In that regard, this course is a companion to DPET 831: Quantitative Methods in Clinical Research, a course to be taught each year in the spring semester.
Spring
Graduate Course, PharmD Course