Patient Preference Workshop
Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation
Thursday, Dec 7 (Day 1): 8:30 a.m. – 5:00 p.m. (Registration begins at 7:30 am)
Friday, Dec 8 (Day 2): 8:00 a.m. – 4:00 p.m. (Registration begins at 7:00 am)
Location TBD, Washington DC Area
Hosted by Johns Hopkins, University of Maryland, UCSF-Stanford, Yale-Mayo Clinic, and the Georgetown University Center of Excellence in Regulatory Science and Innovation and the Food and Drug Administration (Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and the Office of Chief Scientist, Office of Regulatory Science and Innovation.
About the Workshop
Patients have unique perspectives about the value of the potential benefits and the impact of potential harms and burdens of their medical treatments. Scientists, clinicians, medical product developers, and regulators play critical roles in evaluating the benefits and risks of medical products. However, only patients live with their medical conditions and make choices regarding their own care. Reliable and accurate methods are needed in order to effectively incorporate patients’ values into decision-making processes.
Patient preference information is qualitative input or quantitative data elicited from patients about the desirability or acceptability of outcomes or other attributes of medical products, focusing particularly on trade-offs. The continued development of methods to elicit patient preference information and enhance its regulatory applications has the potential to contribute to a better understanding of the benefit-risk profiles of some medical products.
This workshop will:
- Present current progress on incorporating patient preference information into medical product benefit-risk assessments
- Provide examples of how patient preference can be collected, analyzed, and presented in a way that matters to stakeholders
- Explore methods for appropriate measurement, interpretation, and adoption of patient preference information in a regulatory context
- Identify future research and capacity needs in order to improve the use of patient preference information in a regulatory context
This workshop is free and open to the public. The intended audience includes patient groups, academia, industry, government, medical product policy makers, physicians, and the general public. This public workshop will be available to view via live webcast and will also be recorded for later viewing.
Please use the links below to pre-register to attend in person or by webinar for each day of the two-day workshop (to attend the full workshop, you must pre-register for Day 1 and Day 2 separately):
Agenda and Speakers
Agenda information and speaker biographies will be posted here when available.
For questions please contact: [email protected].
If you need special accommodations due to a disability, please contact [email protected] at least 7 days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop, no later than November 22, 2017. A request for either interpreting or captioning is to be sent directly to the FDA Interpreting Services Staff at [email protected].