Patient Centered Benefit-Risk (PCBR) Framework

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.