Collaborative Workshop hosted by: Centers of Excellence in Regulatory Science and Innovation (CERSIs) and The Food and Drug Administration*
December 7-8, 2017
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.
- Presented current progress on incorporating patient preference information into medical product benefit-risk assessments.
- Provided examples of how patient preferences can be collected, analyzed, and presented in a way that matters to stakeholders.
- Explored methods for appropriate measurement, interpretation, and adoption of patient preference information in a regulatory context.
- Identified future research and capacity needs in order to improve the use of patient preference information in a regulatory context.
More information on the agenda is available at:
Tommy Douglas Conference Center (TDCC) at 10000 New Hampshire Ave, Silver Spring, MD 20903.
* Collaborative Workshop hosted by:
Centers of Excellence in Regulatory Science and Innovation (CERSIs):
- Johns Hopkins University
- University of Maryland
- University of California, San Francisco (UCSF)-Stanford University
- Yale University-Mayo Clinic
- Georgetown University
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)
- Office of Chief Scientist, Office of Regulatory Science and Innovation (OCS/ORSI).
- Day 1, part 1 - https://collaboration.fda.gov/p5bf2psb0r3/
- Day 1, part 2 - https://collaboration.fda.gov/p6qtesotoog/
- Day 1, part 3 - https://collaboration.fda.gov/p9cr24add9f/
- Day 2, part 1 - https://collaboration.fda.gov/p2xzoujsi9a/
- Day 2, part 2 - https://collaboration.fda.gov/p891u17gfhk/