MiCOAS

As part of Patient Focused Drug Development efforts, the FDA’s Center for Drug Evaluation and Research initiated a pilot grant program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific diseases using patient input (Grant program: RFA-FD-19-006). In September 2019, the FDA awarded grants to three projects which focused on creating a set of endpoints with input from people living with certain diseases (and their parents in the case of infants and young children). Click here to read about all three projects: Funded projects.

One of the funded projects was the Migraine Clinical Outcome Assessment System (MiCOAS), led by RJ Wirth, PhD of VPG and Richard Lipton, MD at Albert Einstein College of Medicine and Montefiore Medical Center. The overarching purpose of this grant is to develop a publicly available core set of migraine endpoints and their related COAs for migraine, incorporating input from people living with migraine at each step of the way.

A list of our current MiCOAS publications and presentations is provided below. We will also be providing project materials (protocols, reports, etc.) as we progress through this project and publications have been completed. If you are interested in licensing any of the MiCOAS tools, please use the box below.