The MDIC Patient Centered Benefit-Risk (PCBR) Project grew out of FDA’s Centers for Devices and Radiological Health (CDRH) emphasis on benefit-risk assessment as a central component of the medical device approval process. CDRH’s 2012 “Guidance for Industry and Food and Drug Administration Staff Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” discusses the importance of bringing the patient’s perspective into CDRH benefit-risk assessments, and recommends that sponsors interact with FDA staff regarding the development of patient centered benefit-risk information. However, the document does not discuss in what situations or how sponsors should collect and present that information.
Given that there are no widely accepted approaches for assessing patient preferences that have been used in the regulatory process to date, MDIC saw an opportunity to help industry and the FDA think about when and how patient preference information might be incorporated into regulatory decision making. To oversee this project, the MDIC set up a PCBR Steering Committee consisting of interested participants among MDIC’s member organizations supplemented with experts in decision science and preference assessment methods from academia and other organizations. The members of the PCBR Steering Committee are listed in Exhibit 1-2 of the report.
The Steering Committee divided the PCBR Project down into two complementary efforts:
- The development of a “framework” for incorporating patient preference information into benefit-risk assessment, which became this “Framework Report;” and
- The development of a “catalog of methods” that can be used to collect and analyze patient preference information, which is the “Catalog of Methods” included as Appendix A. The MDIC PCBR Steering Committee contracted the development of the Catalog of Methods to RTI Health Solutions with the assistance of a “Catalog Working Group” that included experts in a variety of methods related to assessing patient preferences, as listed in Exhibit 1-4. Financial support from a FDA BAA contract (HHSF223201400011C) made this Framework Report possible, and was primarily used to fund the work of RTI and outside experts on the Catalog.