Course Description

410.648 - Clinical Trial Design and Conduct

Through a case study approach, this course will cover the basic design issues of clinical trials, specifically targeting the Protocol, Case Report Forms, Analysis Plan, and Informed Consent. The design of a specific trial will be studied to illustrate the major issues in the design of a study, such as endpoint definition, control group selection, and eligibility criteria. The course will also cover the analysis plan for a study, including approaches that are central to clinical trials such as stratified analysis, adjustment factors, and "intention-to-treat" analysis. The planned analytical techniques will include the analysis of correlated data (i.e., clustered data, longitudinal data), survival analysis using the proportional hazards (Cox) regression model, and linear models. A semester-long project will include the creation of a Protocol, Case Report Forms, and Informed Consent. Prerequisites: 410.645 Biostatistics or equivalent (Required); 410.651 Clinical Development of Drugs and Biologics (Recommended)