A full website to disseminate all current and future MiCOAS work is under development and will be published soon!
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 is the Migraine Clinical Outcome Assessment System (MiCOAS). The overarching purpose of this grant is to develop a publicly available core set of migraine endpoints and their related clinical outcome assessments for migraine, incorporating input from people living with migraine at each step of the way. This project is led by RJ Wirth, PhD from Vector Psychometric Group and Richard Lipton, MD at Albert Einstein College of Medicine and Montefiore Medical Center.
The goal of this project is to develop and standardize a core set of endpoints and related clinical outcome assessments for use in migraine clinical trials. These endpoints will be developed based upon input from people living with migraine, attempting to capture what is important to them in treatment. The project is a multi-year, multiphase project and we (the MiCOAS team) are currently completing the second year of the project. In the first phase of the grant, we assembled a group of stakeholders (substantive research experts, patient advocates, clinicians, drug developers, measurement experts, regulators, and payers) to guide the project. We then conducted a comprehensive systematic review of the migraine literature to understand the currently used outcomes in migraine trials. We examined the endpoints and outcomes that were reported in over 1400 academic articles describing acute (treatments for lessening an active migraine attack) and preventive (treatments for preventing or reducing the severity of migraine in general) clinical trials for migraine. The full reports are currently available on this page and peer-reviewed publications based on the reports are available for both preventive and acute migraine trials.
The next stage of research was conducting interviews with people living with migraine to gather their views and opinions on their experiences with treatment, the impact of migraine on their lives, and what they want and expect from migraine treatments. We wanted to ensure that the endpoints that we identified from MiCOAS team knowledge and the literature reviews were, in fact, relevant and meaningful to people living with migraine. We also wanted to learn about the experience of living with migraine and experiences with treatments and healthcare to determine if existing endpoints and outcomes are relevant, learn and confirm the proper language and context for describing outcomes, and identify areas important to people with migraine that could be the focus of new outcomes developed by the MiCOAS team. We also included questions to the interview in light of the 2020 global COVID-19 pandemic to determine the impact that the pandemic has had on migraine, either directly or indirectly. The results of this work will be publicly available soon; several posters and presentations from these interviews will be presented at the 2021 American Headache Society scientific meeting.
What we learned from these interviews will help guide the next phase of work, which will include additional qualitative interviews with people with migraine to focus on the refinement of existing measures or the development of new measures so that clinical trials may include patient-focused and statistically sound tools for assessing what matters to people with migraine when evaluating new migraine treatments.
For more information or if you have questions, please contact us at MiCOAS@VPGcentral.com.