TL42: Incorporating Patient Preferences Evidence into Regulatory Considerations
*Martin Ho, Center for Devices and Radiological Health, FDA 

Keywords: patient preferences, benefit-risk assessment, decision science

On November 4, 2014, the FDA published a Federal Register Notice (FRN) to solicit input from stakeholders on strategies to obtain the views of patients in development of medical product and ways to account for patients' input in the regulatory process under the Food and Drug Administration Safety and Innovation Act. This FRN reflects that the principle of patient-centered health care has been widely accepted in the US.

Medical Device Innovation Consortium (MDIC) is a public-private partnership between FDA-CDRH, patient groups, industry, and sister HHS agencies (e.g., CMS, NIH, PCORI). The MDIC was awarded a FDA Broad Agency Agreement to assemble a group of experts and FDA-CDRH reviewers to create two important deliverable documents: The Catalog and Framework of Methods for Assessing Patients Preferences for Benefits and Harms of Medical Technologies. The Catalog document describes an extensive collection of existing quantitative methods of eliciting and analyzing various types of patient preferences. The Framework document not only identifies in what situations patient preference data would be informative, but it also provides important context in which how these methods are applied at various stages of medical product life cycle. These two reports will be released in May, 2015.

In light of these developments, we will discuss how various types of quantitative patient preferences data can be elicited, assessed, and applied at different stages of medical product life cycles in this round table. In particular, we will focus on how the patient preference data can potentially be incorporated into FDA’s regulatory decision making process in the benefit-risk assessment context.