Today, the Medical Device Innovation Consortium (MDIC) releases their Patient Centered Benefit-Risk (PCBR) Framework. This framework and the accompanying catalog of methods address the incorporation of information on patient preferences regarding benefit and risk into the regulatory assessments of new medical technologies.

CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of this framework, and joins colleagues from the National Health Council, Focused Ultrasound Foundation, and FasterCures for the Discussion on Patient Group Perspective during today’s release. This public event is hosted in Washington, DC and attendees are welcomed to join via webinar, as well. For registration information, click here.

“Before approving a new medical device, regulators must evaluate its safety and effectiveness. One of the most important questions they ask is whether the clinical benefit of a device outweighs its risk. It makes sense to consider that question from the perspective of patients as well as researchers and clinicians.”
–MDIC

Bray Patrick-Lake also manages CTTI’s project on Best Practices for Effective Engagement with Patient Groups around Clinical Trials. This project seeks to identify best practices for engaging patient groups that will lead to more efficient and successful clinical trials.