On October 15, 2018, the Celiac Disease Foundation submitted a letter of support for the National Health Council’s (NHC) comments to the FDA’s Request for Information (RFI) regarding Standard Core Clinical Outcome Assessment and Endpoint Sets (CCOAES). The NHC’s letter to the FDA included the Foundation’s input from our medical advisory and scientific community.
The FDA’s RFI seeks to inform plans to develop a standard set of disease-specific Clinical Outcome Assessment (COA) measures and endpoints that would be available to the public. The goal is to ensure clinical research is focused on the outcomes that matter most to patients and reflect changes in disease burden, treatment burden, and physical function.
As a member of the National Health Council, and an advocate for patient-centered outcomes research, the Celiac Disease Foundation was pleased to collaborate on the NHC’s comments and to submit a letter in support of this worthy effort.
Read the Foundation’s Letter of Support and the National Health Council’s full letter here .
About the National Health Council:
The NHC is the only organization that brings together all segments of the health community to provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 120 diverse national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process.
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The Foundation Submits Letter of Support to FDA on Developing Patient-Focused Clinical Outcome Assessments and Endpoints