Regulatory Focus™ > News Articles > FDA Plans Study on How Obese Patients Make Decisions, Perceive Risk

FDA Plans Study on How Obese Patients Make Decisions, Perceive Risk

Posted 18 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced it is looking to conduct a study probing how patients perceive risk and come to make decisions, particularly in the context of obese patients seeking medical interventions to reduce their weight.

FDA notes in its 18 April Federal Register posting that a whopping 35.5% of men and 35.8% of women in the US are reportedly obese-increasing from 25.7% and 27%, respectively, in 2000.

Understanding how this demographic makes medical decisions will be crucial to deciding how to regulate medical products seeking to make a dent in the obesity epidemic, says FDA.

In order to help its advisory panels determine the "acceptable risk threshold of a medical intervention against its effectiveness as demonstrated in clinical evidence," FDA said it plans to initiate a pilot study to "quantify obesity patients' benefit-risk preferences."

The agency plans to sample roughly 1,000 obese adults in the US, of which 450 will be expected to participate in the complete pilot study.

"Final results will provide an estimate of the maximum levels of various treatment-related risks that obesity patients would be willing to accept to achieve specific levels of weight loss or improvements in weight-related diseases" explained FDA. "These results will be used to investigate the viability of choice-format surveys as a way to quantify patients' risk tolerance for the therapeutic benefits of weight-loss devices."


Read more:

FDA - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Decision Analysis, A Risk-Tolerance Pilot Study


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