SYMPOSIUM: TRANSLATING PATIENT PREFERENCE RESEARCH INTO REGULATORY PRACTICE

A variety of scientific methods are now commonly used to quantify patient preferences. During 2015, there have been several initiatives designed to incorporate patient-preference information in policy-relevant decisions – especially regulatory benefit-risk analysis. The Medical Device Innovation Consortium (MDIC), a public-private partnership that engaged industry, government, and patient stakeholders, developed both a framework for identifying when and how patient preferences could be incorporated in regulatory submissions for medical devices and a catalog of methods that would be suitable for quantitatively assessing preferences. The FDA’s Center for Devices and Radiological Health (CRDH) has further facilitated the translation of patient preference research into practice through the release of draft guidance detailing how patient preference information can be used in regulatory submission, review and labeling of medical devices. Furthermore, CRDH completed a case study on weight-loss device preferences and demonstrated how this information can be utilized to inform regulatory decision-making. Finally, Parent-Project Muscular Dystrophy (PPMD) demonstrated that patient organizations can play a leading role in conducting patient-preference study that can be informative to regulatory decisions. This session will highlight how patient preference information can be translated in to practice within the context of regulatory benefit-risk analysis and in promoting patient-focused drug/device development.