Incorporating Patient Preferences in Medical Treatment Development and Review: The MDIC Patient-Centered Benefit-Risk Assessment Project

• Activity Number: 620
• Type: Invited
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Bennett Levitan*
• Companies: Johnson & Johnson
• Keywords: benefit-risk ; preferences ; devices ; CDRH ; MDIC

Abstract

Incorporating the preferences of patients into medical treatment development and benefit-risk decisions has become increasingly important. While there is general agreement that these preferences should be used, there is considerable uncertainty as to how they can be assessed and used in a regulatory context. What methods are appropriate for health authorities? What factors determine when preference information would be valuable? When in the product lifecycle should they be applied? The Medical Device Innovation Consortium (MDIC) is a public-private partnership co-sponsored by FDA CDRH, NIH, CMS, industry, academia and patient groups. The MDIC Patient Centered Benefit-risk Project addressed these issues by developing (i) a catalog of methods for preference assessment, characterizing their capabilities and limitations and (ii) a framework for their application in device regulatory submissions. The Framework was released in May, 2015 and was developed to serve as a component of FDA CDRH's planned guidance document on patient preference assessment in device regulatory review. This presentation provides an overview of the project and key features of the Framework.