Qualifying Patient-Reported Outcome Measures (PROMs) for Assessing Fatigue

Building on work as the PROMIS Network Center, AIR is leading efforts to obtain Food and Drug Administration (FDA) qualification of the PROMIS fatigue measure for use in clinical trials of therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). A profoundly disabling condition, ME/CFS has no current FDA-approved therapy. The pharmaceutical industry has been reluctant to develop therapies for ME/CFS, in part, because of a lack of confidence that there is a measure of therapeutic effectiveness that FDA would accept.

AIR will collaborate with a patient co-investigator and the Bateman Horne Center for ME/CFS and Fibromyalgia to produce evidence related to the psychometric reliability and validity of the PROMIS fatigue measure for patients with ME/CFS. AIR also is contributing to this evidence by collecting primary data through one-on-one patient interviews, which, once analyzed and documented, will be added to the evidence package. Funding for this research is provided by an FDA contract to advance regulatory science for underserved populations. ;

Managing Researcher