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FDA Validates Tool For Incorporating Patient Preferences In Regulatory Decisions

A pilot study that explored how much risk patients would be willing to tolerate from a device implant in order to achieve significant weight loss is helping CDRH regulators understand how to accurately and reliably measure patient preferences. The goal is to start incorporating those preferences into regulatory decisions for certain devices, officials explained at a Sept. 18-19 workshop.

Results from a recent FDA survey that explored how much risk patients would tolerate to lose weight through a device-based procedure provide insights that can be adapted to benefit-risk analyses for other medical treatments, CDRH regulators say.

“We wanted to see if it was feasible to elicit patient preferences, and more than that, to assess quantitative preferences and to use that in our review process,” said Telba Irony, chief of the general surgical devices branch in CDRH’s Office of Surveillance and Biometrics, who developed the pilot study with the aid of consultants at RTI Health Solutions

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