It's been almost four years in the making, but the FDA's draft guidance on patient-reported outcome measures has now officially dropped the "draft" designation.
Among the differences between the 2006 draft and the guidance unveiled last week, according to Keith Wenzel, ePRO product director at Perceptive Informatics, is that the document's emphasis has changed to describing how the FDA will evaluate patient reported outcome measures, rather than the draft's approach of describing how sponsors should develop PRO instruments. Patient-stated outcomes measured during product development drive the claims allowed by FDA in product labeling.
Another difference is that the guidance eliminates a contentious section in the draft on defining a so-called minimum important difference, Wenzel says in an interview. The section covered methods used to interpret clinical trial results based on PRO outcomes. It specifically addressed the detection of statistically small changes and methods to determine whether such changes are meaningful.
Wenzel says that in his analysis, most of the electronic PRO vendors are "well prepared" in meeting the guidance. The Perceptive Informatics ePRO product today meets guidance requirements, he says, but sponsors will likely have to provide some additional documentation in their submissions concerning the electronic data collection process compared with any existing paper-based process. In any move from paper to electronics, he says, you'll need to follow a rigorous process demonstrating that the two forms provide comparable data.
He also mentions that the ePRO solution, via its automatic date and time stamps, addresses the FDA concern of when trial subjects complete their patient diaries. Paper diaries may not have been completed in timely fashion, though they sometimes indicate otherwise.
- here's the guidance