Clinical Study Design for Opioid Use Disorder Devices is Subject of FDA Guidance

Recommendations for study design to facilitate innovation in development of devices, such as deep brain, transcranial magnetic and spinal cord stimulations, intended to treat opioid use disorder (OUD) are the subject of a draft guidance issued July 27.

The document, “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder,” says key considerations for clinical studies of devices intended to treat OUD include inaccurate participant reports of drug use, high rates of missing data, the effects of concomitant drug treatments and the need to demonstrate the durability of the treatment.

The draft guidance also recommends that OUD device studies to support marketing submissions should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans. 

Read the draft guidance here.

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