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Patient Organizations May Apply to Join Natural History Study Project


 

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The U.S. Food and Drug Administration (FDA) has awarded NORD a $250,000 grant to develop 20 natural history studies for 20 rare diseases, based on a lottery system. Patient organizations may submit an application on the NORD website to be included in the lottery for this project.

“NORD’s Natural History Study Project tackles one of the greatest needs and an inherent challenge of the rare disease community: having enough longitudinal data to help medical researchers better understand how these diseases develop and progress over time,” said NORD President and CEO Peter L. Saltonstall.

NORD developed its Natural History/Registry Platform with input from patient organizations, researchers, and regulators. To date, NORD has launched seven disease-specific studies, working with rare disease patient groups. The platform has been widely praised as a model for supporting rare disease studies.

As part of the grant, NORD will work with rare disease patient organizations and FDA to establish a registry toolkit containing best-practice tools and templates to help in the design of future natural history studies to support rare disease research.

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