*WEBEX ONLY* Patients' Stated Risk Tolerance and Regulatory Decision-Making: Can We Trust the Numbers?
Regulatory evaluation of new medical products requires weighing the benefits and risks of these technologies. While these evaluations increasingly rely on patient input, challenges remain in the collection of patient risk-tolerance data to inform regulatory decision-making. Dr. Gonzalez will discuss some of these challenges and present key implementation elements of stated-preference methods to generate valid measures of patients' risk tolerance.
About Our Speaker
Dr. Gonzalez's research focuses on the design of stated-preference survey instruments and the use of advanced statistical tools to analyze stated-preference data. He co-led the first FDA-sponsored preference study which was highlighted in their precedent-setting guidance for submitting patient-preference evidence to inform regulatory benefit-risk evaluations of new medical devices. He also collaborated with the Medical Devices Innovation Consortium to prepare the first catalog of preference-elicitation methods (part of the Patient-Centered Benefit-Risk Assessment Framework) that was suitable for benefit-risk assessments of medical devices. Dr. Gonzalez is currently working with the Center for Devices and Radiological Health at the FDA to support the development of the Center's capabilities for the review of stated-preference data in regulatory decisions.