Latest / Let's Talk Risk! Podcast
Deep Dive: When Patient Preference Becomes Regulatory Evidence
Patient preference is no longer a soft qualitative afterthought.
What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical benefit?
This Deep Dive examines how FDA’s evolving approach to Patient Preference Information (PPI) can turn those tradeoffs into quantitative evidence for regulatory benefit-risk decisions.
Key highlights covered in the audio:
* PPI is not the same as a patient-reported outcome. PROs describe what patients experience. PPI asks what risks patients are willing to accept to obtain a particular benefit.
* Risk tolerance…
The skinny
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