RESEARCH TRIANGLE PARK, NC— RTI Health Solutions (RTI-HS), a business unit of RTI International, partnered with the U.S. Food and Drug Administration to conduct a study on patients' preferences which contributed to the Agency's regulatory decision to approve the Maestro Rechargeable System, a first-of-kind device to treat obesity.
In addition to clinical study results, FDA considered the study results to quantify patients' preferences for benefits and acceptability of risks of various obesity devices. The RTI-HS/FDA study estimated the maximum mortality risk patients were willing to accept for a certain amount of weight loss, and the minimum amount of weight loss sufficient to undergo the risks of a weight loss device. This was the first time a patient preference study impacted a new device approval.
"This obesity preference study allowed us to systematically quantify the tradeoffs patients are willing to make among benefits, harms, and other features of weight-loss devices," said Juan Marcos Gonzalez, Ph.D., senior research economist at RTI-HS. "The study was designed to provide scientific data on patient preferences to inform clinical trial design for obesity devices and it resulted in sufficient data to inform FDA's regulatory decision-making."
Prior to the obesity preference study, the FDA did not have the scientific data to quantify the tradeoffs patients were willing to make among the benefits and risks of a weight-loss device or to use this type of information when assessing the benefits and risks of a new technology to be marketed in the United States.
"This is the first example of a study that measures what actual patients view as acceptable benefits and risks for a medical device—in a way that the FDA can apply to regulatory decision making," said Kathryn O'Callaghan, acting Associate Director for Science and Strategic Partnerships in the FDA's Center for Device and Radiological Health. "As a regulatory agency, it is important that, when appropriate, the FDA take into account preferences of the whole spectrum of intended users of a medical intervention."
This is the first FDA-approved obesity device since 2007. It is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.
In the patient-preference study, obese respondents were asked to choose the most-preferred option from a set of two or more alternatives indicating the maximum amount of mortality risk accepted for a percentage of total body weight loss lasting a certain period of time. For example, to accept a device with a .01 percent mortality risk, a patient would want about a ten percent total body weight loss for five years.
The results of the patient-preference study were recently published in Surgical Endoscopy.
Please see this FDA press release for more information on the Maestro Rechargeable System.