Journal Article Gives Insight On Using Personal Preference Information In Clinical Trials
The FDA has expressed interest in using patient preference information (PPI) to make regulatory decisions for medical devices. A recent article gives recommendations to medical device sponsors who want to study PPI in clinical trials.
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As the agency continues to incorporate more patient-preference data into its regulatory process, it is asking stakeholders on the kinds of diseases and other factors it should consider when evaluating patient-preference information. The feedback is ultimately meant to inform regulators and sponsors about what patients want as they develop products.
US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.
The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.