FDA to Require Agency-Wide Training in Use of Patient-Reported Outcomes

A new requirement has been added to the FDA’s Reviewer Certification Program — training in the development, evaluation and use of patient-reported health outcomes, the agency said in its first report on PROs in medical device premarket submissions and post-market studies.

The training course was developed this spring so agency staff can reflect the interest seen among devicemakers and study sponsors, according to the report, which encourages the use of PROs in pre- and post-market clinical studies and regulatory decisions.

The report lists the benefits to industry in using PROs, including shaping the design of a clinical trial to focus on outcomes that are important to patients and the treatment they receive, which in turn may reduce the number of clinical visits in the trial.