Roberta J Wong
Offered at a graduate level periodically by faculty members within the Department of Bioengineering; concerns areas of research activities with current and topical interest to bioengineers. Prerequisite: undergraduate or graduate courses (or equivalent) determined individually for each special topic.
Course Description: This clinical development course reviews the major concepts under which clinical trials are designed and implemented. The themes of ethical treatment of human subjects and Good Clinical Practice (GCP) are emphasized. Topics include: phases of clinical trials, the role of the Food and Drug Administration and Institutional Review Boards, and ethical principles, including informed consent and conflict of interest. During the course, each student will develop a life cycle plan for an investigational product and also work on a team with other students to prepare a pre-NDA presentation on an investigational product. V
Student learning goals
List the major sections of a target product profile
Discuss the role of the FDA in approving drugs for the US market
Describe drug efficacy and safety
Review the function of an Institutional Review Board and how they impact clinical trial subjects
List the components of a product life cycle plan and discuss how this is used for drug development
General method of instruction
A combination of live lectures, recommended reading, case studies and discussion will be utilized in this course.
All students will have completed the basic biosciences coursework.
Class assignments and grading
Students will create a target product profile, and work in teams to create a group presentation. Time will be given in class to work on group presentations.
Grading will be based on the writing assignments and the oral presentations.