PURPOSE: To review recent novel uses of patient preference information in regulatory decision-making, identify lessons learned, and address barriers to use and related methodological opportunities.

DESCRIPTION: This session will be an opportunity for dialog between the FDA, industry, patients, and patient preference researchers about the use of patient preference information (PPI) in regulatory decision-making. Previously, one study on obesity devices was available to demonstrate the potential US medical device regulatory value of PPI. Over the past year, there have been several examples of patient preference studies used to help inform FDA decision-making. The purpose of this session will be to discuss lessons learned and brainstorm opportunities for methodological and implementation research for regulatory applications.

Ms. Saha, FDA, will summarize two recent examples of the use of PPI in regulatory decision-making, including lessons learned about designing the PPI study and potential approaches to integrating this information into the evaluation of medical devices. Ms. Christopher, MDIC, will discuss frontiers in collecting and using PPI, including ongoing studies addressing novel approaches to using PPI in clinical trial designs. Ms. Moore, WomenHeart: The National Coalition for Women with Heart Disease, will discuss her experiences as a patient advisor of a patient preference study. Dr. Gonzalez, Duke University, will provide a summary of current methodological challenges and research opportunities in the design of preference studies.

Speaker presentation length will be 10 minutes each, with 20 minutes for an audience interactive session.