University of California, San Francisco (UCSF) – Stanford University CERSI

Wednesday, October 2, 2019

About the Presentation

The inclusion of the patient’s voice in shared health care decision making has progressed from the physician’s office to the regulatory decisions made by the FDA. In 2013, the FDA launched the “Patient Preference Initiative” to incorporate patients’ views as scientific, empirical evidence, when appropriate. This led to CDRH and CBERs’ collaboration with the Medical Device and Innovation Consortium (MDIC) on a report cataloguing assessment methods published in 2015. This report was the basis for FDA’s CDRH and CBER draft guidance defining patient preference information for medical devices and outlining approaches to its measurement and use. Since then, the FDA has initiated multiple collaborations to advance the science and define the usability of patient preference information across different stakeholders at a rapid rate.

All those who evaluate new innovative biologics, drug products and devices need to know what patient preference information is and how it is measured and incorporated into regulatory decisions. Case studies will be presented to highlight what patient preference information is, what is being done within a variety of medical product areas to advance patient preference, and how the patient viewpoint is informing public interactions with the FDA. We provided more detail into one specific quantitative method for measuring patient preference based on a behavioral economic framework. You will learn how this choice based conjoint measure is developed, and answered by patients, and what their resulting preferences tell us. Other case examples will demonstrate how patient preference has already been used in approval decisions, how it was being used to strengthen patient advocacy, and how other stakeholders were involving themselves. These case examples provided a glimpse into how patient preference was generated to serve as evidence in decision making, allowed enough detail to understand the quantitative measurement, and also placing patient preference into the regulatory context.

About the Presenter

Leslie Wilson, PhD, is a Professor of Health Policy and Economics in the Departments of Medicine and Clinical Pharmacy at the University of California, San Francisco (UCSF). Her current research focuses on understanding the patient’s viewpoint by developing behavioral economics methods to understand how they trade off the risks and benefits when making difficult treatment decisions.

As one of the founding members of the International Association of Health Preference Research (IAHPR) and other groups developing and validating health preference methods, years of experience in the pharmaceutical industry examining the economic value of drugs, combined with her previous practice as a Registered Nurse, has given her the ideal combination of skills to advance the area of patient preference.

Dr. Wilson is currently leading two patient preference projects using quantitative discrete choice conjoint analysis in collaboration with the FDA for innovative devices and biologics. She is a member of the UCSF-Stanford Center for Excellence in Regulatory Science and Innovation (CERSI) which is acting as the flashpoint for FDA collaborations around developing patient preference methodology and workforce development to ensure quality and usefulness to the FDA.

Recording

https://collaboration.fda.gov/pzvsmbs36onz/

FOR QUESTIONS:

Please contact Jessika Alfaro at [email protected]