Clinical Trial Design: From Initial Concept to Regulatory Approval

Catalog description

This course teaches the basic elements of clinical trial design, implementation and analysis including small phases of clinical trials. Overall early phase clinical trial concepts including dose finding, initial safety assessment deleted text, biomarker and initial activity assessments will be taught. Later stage concepts such as dose refinement, safety and efficacy will also be covered. The course will teach all aspects of clinical trials including initial concept, study design, synopsis writing, overall protocol development, review and approval by regulatory authorities and Institutional Review Boards (IRB), site selection and qualification, drug accounting, data and safety monitoring, data collection and analysis, unblinding procedures, study and site close out and clinical study report writing. Students will gain experience by analyzing existing protocols, studies and data. Basic statistical knowledge expected. Open to all graduate students, fellows, and faculty.