Preclinical and Clinical Study Design
Learning Objective:Students will more thoroughly understand device tissue interactions and how they may be studied with pre-clinical animal models to predict safety and performance in human clinical trials that are necessary to gain regulatory approval for marketing.
To assist students in building a solid foundation for cutting-edge engineering research. The student will be able to: 1. Recognize the importance of an integrated marketing, regulatory, pre-clinical, and clinical strategy for bringing new medical devices to market; recognize the phases in the product development life cycle when pre-clinical and clinical testing is implemented. 2. Appreciate the bioethics concerns in animal and human testing. 3. Understand the difference between feasibility, pilot, and pivotal studies and when each is used in product development and marketing. 4. Appreciate the role of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) in evaluation of new medical devices. 5. For a sample product, select an animal model or study population, determine appropriate end points for efficacy of treatment, and design an appropriately-powered study to detect differences, if they exist. 6. Understand the practical issues of study logistics such as selecting a site or contract research organization, developing timelines and budgets, maintaining communication, documentation and monitoring, and issuing final reports. Tentative Syllabus
Topics Covered:Overview of Medical Device Development; Ethics Concerns in Animal and Human Trials; Pre-Clinical Evaluation Strategies for Orthopedic, Neurologic, and Cardiovascular Medical Devices; Experimental Design; Issues in Managing or Overseeing Human Clinical Trials; Integration of Studies for Regulatory Approval.
Applied / Theory:
Web Content:Syllabus, Grades, Lecture Notes, Homework Assignments & Message Board
Projects:Clinical protocol for study. Not job-related.
Exams:Regular quizzes over material covered.
Textbooks:Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.
Required: Biodesign: The Process of Innovating Medical Technologies, Paul G. Yock, Cambridge University Press, ISBN:9781107087354