Rare Disease Clinical Outcome Assessment Consortium Announced by C-Path

The Critical Path Institute (C-Path) has launched its Rare Disease Clinical Outcome Assessment Consortium. The Consortium is a public-private collaborative effort to help select clinical outcome assessment parameters for therapeutics and products targeting rare diseases. Partners in this effort include the FDA, National Organization for Rare Disorders, biopharma companies, patient communities, and researchers.

According to AZ Bio, “The underlying premise for the Rare Disease COA Resource is that, for rare diseases that share common characteristics, existing COAs may be used or modified for use as endpoint measures for treatment trials. By identifying existing measures that are potentially fit-for-purpose, the considerable time and cost associated with the development of new COAs may be reduced. With the support of funding provided by FDA, work toward developing the Rare Disease COA Resource has been underway since 2019.

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(Source: AZ Bio, January 13^th, 2022)