Course Description: |
Clinical Trials Overview: Methodology and Practice is designed to teach researchers at all levels (investigator, study coordinator, study monitor, study staff) the fundamentals of a good clinical trial in the evaluation of a new drug or device. Students learn about the phases of drug discovery from bench to market gaining a global perspective on the regulatory issues pertaining to each phase. In addition, students discuss and critique trial design, including adaptive trial strategies, randomization plans, quality assurance, treatment masking and human subjects’ protection as well as learning about the business of clinical trials (managing external funding, budget processes, and analyzing cost-effectiveness and cost-benefit data). The roles of the investigator, sponsor, coordinator IRB, DSMB and others are reviewed. Epidemiological methods in clinical trials will also be discussed. |
