Dive Brief:
- The Food and Drug Administration has finalized guidance on clinical considerations for studies of devices intended to treat opioid use disorder.
- Through the guidance, the FDA is aiming to help companies manage challenges such as inaccurate participant reports of drug use and show the safety and effectiveness of medical devices.
- The final guidance, which the FDA published Thursday, is largely unchanged from the draft the agency released for consultation in July 2023. No device manufacturers or trade groups shared public feedback on the draft.
Dive Insight:
The FDA has identified medical devices as interventions that can further its work to address the opioid overdose crisis. However, the complexity of opioid use disorder creates challenges for the developers of devices designed to treat the condition. The FDA named high rates of missing data and the need to track patients for long enough periods to show durable effects among the challenges sponsors face.
Seeking to help companies overcome the problems, the FDA has finalized its guidance on pivotal clinical trials that are intended to support submissions for authorization of devices to treat opioid use disorder. The guidance does not apply to diagnostics, pain treatments or combination products.
The main section of the guidance addresses different aspects of clinical study design such as the patient population, the appropriate length of a trial and the clinical outcomes. The recommendations reflect issues encountered in the past, such as difficulties retaining participants and the resulting high rates of missing data.
Device makers should ensure “adequate blinding of the treatment assignment to minimize decisions to drop out,” the FDA said, and use conservative estimates for missing data when analyzing study results. The FDA wants sponsors to describe their methods to account for missing data in full detail before the start of a study.
A discussion of clinical outcomes is the largest section of the document. The section features a non-exhaustive list of outcomes that sponsors can use as their primary and secondary endpoints. When choosing from proposed endpoints such as change in drug use patterns, reduction in adverse effects and patient-reported outcomes, the FDA recommends considering factors like patient population.