- The U.S. Food and Drug Administration released a draft guidance on Thursday for designing clinical trials of medical devices intended to treat opioid use disorder (OUD).
- Through the guidance, the FDA aims to address challenges associated with OUD trials including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.
- The FDA, which is accepting feedback on the draft until Oct. 26, envisages the guidance helping the medtech industry collect more comprehensive, timely and diverse data to support filings for approval.
The FDA has identified medical devices as part of the solution to the opioid crisis. In 2018, the regulator launched an innovation challenge intended to encourage development of medical devices that detect, treat and prevent addiction, as well as products that address diversion and treat pain.
As sponsors have worked to generate pivotal data on devices for treating OUD, the FDA has identified a set of challenges specific to the therapeutic area that the draft guidance is intended to address.
“This draft guidance for device studies should prompt industry to collect more comprehensive, timely and diverse data to support device submissions that may help improve the lives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,” FDA Commissioner Robert Califf said in a statement.
The draft states OUD device trials can be affected by subjective outcomes, placebo effects, concomitant treatments and potential bias. As such, pivotal trials should be well-controlled and designed, for example by having a well-defined population, appropriately monitoring drug use, controlling bias and including a suitable follow-up period.
Across the draft, the FDA provides details of how sponsors can achieve those objectives. The agency is advising sponsors to measure opioid use with both self-reports and “objective verification measures.” Examples of objective measures include random and scheduled urine tests and “validated drug detection technologies as they become available.” Objective results should take precedence over self-reports.
Other sections of the draft address the duration of studies — with the FDA recommending that treatment lasts at least six months — and how to maximize participant retention and reduce missing data. The FDA also discusses clinical outcome measures, such as changes in drug use patterns, that can be primary and secondary endpoints.