I have an update on the progress of the ME/CFS Outcomes Measures Working Group working with FDA.
As I reported in March 2015, the FDA helped convene a Working Group comprised of representatives from FDA, NIH, CDC, and academia in order to create and qualify a clinical outcomes assessment tool for ME/CFS. This is critically important in the drug development process. If FDA officially qualified an assessment tool, then it could encourage drug developers to get into the ME/CFS area. Such a tool does two things for drug developers: a) it saves the money of creating and qualifying the tool and b) they know that FDA will accept use of that tool in clinical trials.
I am happy to report that our effort to create the tool has officially been accepted into FDA’s Clinical Outcome Assessment Qualification Program. This means that FDA has reviewed and provided guidance on the design of a study to create the tool. The Working Group plans to test whether items from NIH’s PROMIS question bank are applicable in ME/CFS.
The Working Group understands that this is not simply a matter of measuring fatigue. In fact, figuring out how to measure post-exertional malaise is one of the puzzles we are tackling. It may turn out that PROMIS items don’t work for the ME/CFS population, but we need to test that. Starting from scratch to create a new measure takes much longer and is more expensive.
Right now, we are actively seeking funding for the study. I’ll keep you posted as things develop.