Patient Centered Benefit-Risk (PCBR) Framework

MDIC Patient Centered Benefit-Risk Assessment:

Introducing the Framework for Integrating Patient Perspective into Medical Device Benefit-Risk Assessments

In 2015, MDIC held a public event for the release of its Framework & Catalog of Methods for ‘Incorporating Information on Patient Preferences Regarding Benefit and Risk into the Regulatory Assessments of New Medical Technologies’. As a result of CDRH’s 2012 Guidance that discusses the importance of bringing the patient’s perspective into the CDRH benefit-risk assessments, MDIC brought together a steering committee with members from the medical device industry, government and patient centered non-profits to develop a framework for how sponsors and regulators might incorporate the patient perspective on benefit and risk. This Framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including patient benefit-risk in a regulatory submission and when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory process.

Introductory Remarks from MDIC- Watch
     Bill Murray, President and CEO, MDIC
 Introductory Remarks from CDRH Watch
     Jeff Shuren, Director, FDA Center for Devices and Radiological Health
Overview of the Framework for Integrating Patient Perspectives into Medical Device Benefit-Risk Assessments- Watch
     Ross Jaffe, Versant Ventures & National Venture Capital Association;
     Board Champion for MDIC Patient Centered Benefit-Risk Assessment
Overview of the Catalog of Patient Preference Assessment Methodologies- Watch
     Brett Hauber, RTI Health Solutions
Framework Section Overviews- Watch
     Framework Section II: Bennett Levitan, Johnson & Johnson
     Framework Section III: Diana Salditt, Medtronic
     Framework Section V: Brett Hauber, RTI Health Solutions
     Framework Section VI: Telba Irony, FDA
Discussion on Catalog and Framework- Watch
     Discussion panel: Brett Hauber, Telba Irony, Bennett Levitan, Bryan Olin, Diana Salditt
     Discussion moderator: Bill Murray
CDRH Perspectives on Patient Preferences- Watch
     Discussion panel: Bob Becker, Martin Ho, Telba Irony, Kathryn O’Callaghan, Anindita Saha
     Discussion moderator: Kim McCleary, Fastercures
Patient Group Perspectives on Patient Centered Benefit-Risk Assessment- Watch
     Stephanie Christopher, MDIC
Discussion on Patient Group Perspective- Watch
     Discussion panel: Marc Boutin, Jessica Foley, Kim McCleary, Bray Patrick-Lake
     Discussion moderator: Kathryn O’Callaghan
Future Applications of Patient Preferences- Watch
     Ross Jaffe
Discussion on Future Applications of Patient Preferences- Watch
     Discussion panel: Brett Hauber, Martin Ho, Bennett Levitan, Bryan Luce
     Discussion moderator: Bill Murray
Closing Remarks From New FDA Deputy Commissioner for Medical Products and Tobacco- Watch
     Dr. Robert Califf, FDA

Meeting Slides-PDF