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Home » FDA Issues Final Guidance on Pivotal Trials for Opioid Use Disorder Devices
FDA Issues Final Guidance on Pivotal Trials for Opioid Use Disorder Devices
July 15, 2024
The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording medication use, monitoring drug use and other elements.
The nine-page guidance covers six components critical to the design and conduct of trials for OUD devices:
- Defining the patient population and assigning participants to treatment and control groups
- Recording the use of all baseline medications, including those used for treating the disorder prior to treatment with the investigational device
- Monitoring prescribed and nonprescribed drug use
- Setting an appropriate trial duration
- Determining ways to maximize participant retention and prevent missing data through adherence to follow-up schedules and treatment plans
- Selecting primary and secondary outcomes
For example, the FDA believes that these devices display clinically significant benefits when they improve the way patients feel, function or survive, such as by reducing hospitalizations, or make daily life better, such as by enabling the resumption of work, school and other activities.
With that in mind, sponsors “should identify the clinical objectives of the device for the target patient population and align the objectives with the desired indications for use, a relevant definition of a clinically significant benefit, and the choice of effectiveness outcomes” when selecting primary outcomes, the FDA advises.
“FDA recommends the inclusion of secondary outcomes that measure different manifestations of OUD to support the robustness of any evidence of demonstrated clinically significant difference in the primary outcome,” the guidance continues. “The presentation of a consistent and clinically significant difference across an array of outcomes can contribute to the evidence needed to support a marketing submission.”
Read the full guidance here.
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