FDA integrating patient preference into device decisions

FDA has taken a step toward moving patient-centered drug regulation from anecdotal reports collected at open public meetings to a quantitative approach based on data obtained in controlled experiments. In an article published Jan. 1 in Surgical Endoscopy, Center for Devices and Radiological Health staff reported on the "first study designed to provide regulators with quantitative data on patient preferences in support of regulator benefit-risk tradeoff determinations."

CDRH surveyed 540 obese individuals about tradeoffs they would be willing to accept among effectiveness, safety and other attributes of various treatments. Based on the survey data, the center developed a "tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss." For example, it determined that risk-tolerant patients would be willing to accept a device with a 0.01% mortality risk if it were able to produce a weight loss of 10% that lasted at least five years. The survey also revealed that placement of a device through open surgery instead of endoscopically "requires at least 12 months of weight loss to compensate." ...