Sponsors of clinical trials of medical devices to treat opioid use disorder (OUD) face “complex challenges,” the US Food and Drug Administration (FDA) said. In a draft guidance issued on Thursday, the agency stressed that sponsors should consider the makeup of the treatment population, the accuracy of self-reported outcome measures and other factors that could impact clinical development of such devices.
Other challenges include high rates of missing data, the confounding effects of concomitant drug treatments and measuring the durability of the treatment effect of an investigational device.
To address these challenges, FDA said that OUD device studies should have a well-defined study population, appropriately monitor drug use and control for biases. They should also include an appropriate follow-up period, study participant retention plans and data analysis plans.
« We are committed to helping industry develop solutions that are proven to be effective to address the devastation caused by the overdose crisis,” said FDA Commissioner Robert Califf. “This draft guidance for device studies should prompt industry to collect more comprehensive, timely and diverse data to support device submissions that may help improve the lives of those with opioid use disorder. »…
