On May 13th the Medical Device Innovation Consortium (MDIC) released a report on incorporating patient preferences into the FDA’s benefit/risk assessments. It was much anticipated by PPMD as we continue our “aggressive engagement” with the FDA and industry trial sponsors. The report is full of really awesome, nerdy, and technical information and tips for how to best measure patient and caregiver preferences (I have to admit, I’m hooked). Though the report is focused on medical devices, not drugs, the methods and approaches used are the same. It’s the result of a collaboration between MDIC members, the FDA, and experts in assessing benefit/risk balance. Similarly, on May 18th, the Center for Devices and Radiologic Health (CDRH) opened a docket for public comment on their own Draft Guidance on integrating patient preference information.
Why does this matter?
First, it helps to inform our approaches to get YOUR preferences and priorities included in clinical trials and regulatory decision making. Second, it gives us additional ammunition to get the Center for Drug Evaluation and Research to more systematically include family preferences into their decision making. And finally, we are really proud of how our community’s efforts are highlighted in these materials. For example, the MDIC report states that PPMD’s benefit/risk study is a “good example of a broad patient preference study sponsored by a patient advocacy group to help shape the regulatory requirements in a particular area…”. PPMD’s benefit/risk work is also referenced in the CDRH draft guidance document. Our community’s leadership in this area was highlighted at last week’s MDIC Patient-Centered Benefit Risk Assessment meeting, and also at this week’s meeting of the International Society of Pharmacoeconomics and Outcomes Research, where PPMD’s benefit/risk work was described by several of the expert presenters.
PPMD is so proud of the recognition and impact our benefit/risk work continues to have in the medical community. Again, we thank all of you who participated in this study by lending your voice and telling your story.