Clinical Trial Design and Conduct

4 Credits.

This course will cover basic design issues, conduct, and execution of clinical trials for drugs and biologics. Clinical trial design will be analyzed to better understand various clinical trial study designs along with concepts such as endpoint definition, control group selection, and eligibility criteria. Other areas of emphasis will include informed consent, safety monitoring, ICH Good Clinical Practice (GCP), basic statistical concepts, data collection and integrity, trial implementation and regulatory strategy. Various challenges and points to consider for conducting clinical trials in the 21st century will be highlighted along with a close look at regulations. There will be three hands-on projects which will include authoring an informed consent, designing a case report form, and creating a presentation on clinical trial strategy. Prerequisites: 410.651 Clinical Development of Drugs and Biologics (recommended).