title: A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies.
abstract: BACKGROUND
  In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices.
  
  
  METHODS
  A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework.
  
  
  RESULTS
  The MDIC Framework examines what patient preference information is and the potential use and value of patient preference information in the regulatory process and across the product development life cycle. The MDIC Framework also includes a catalog of patient preference assessment methods and an agenda for future research to advance the field.
  
  
  CONCLUSIONS
  This article discusses key concepts in patient preference assessment of particular importance for regulators and researchers that are addressed in the MDIC Framework for patient centered benefit-risk assessment as well as the unique public-private collaboration that led its development.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Martin
authors.initials: M
authors.lastname: Ho
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Anindita
authors.initials: A
authors.lastname: Saha
authors.affiliation: FasterCures, Milken Institute, Washington, DC, USA.
authors.forename: K Kimberly
authors.initials: KK
authors.lastname: McCleary
authors.affiliation: Janssen Research and Development, LLC, Titusville, NJ, USA.
authors.forename: Bennett
authors.initials: B
authors.lastname: Levitan
authors.affiliation: Medical Device Innovation Consortium, Minneapolis, MN, USA. Electronic address: schristopher@mdic.org.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Christopher
authors.affiliation: Medical Device Innovation Consortium, Minneapolis, MN, USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Zandlo
authors.affiliation: Department of Population Health, NYU School of Medicine, New York, NY, USA.
authors.forename: R Scott
authors.initials: RS
authors.lastname: Braithwaite
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: A Brett
authors.initials: AB
authors.lastname: Hauber
mesh_terms: D020811:Biomedical Technology / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D057240:Patient Preference; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
keywords: patient-derived preferences; preference-based measures; preferences; regulatory