What is a natural history study?

There are two types of natural history studies: prospective and retrospective studies.

Prospective natural history studies track the course of a disease in a group of people over time, identifying demographic, genetic, environmental, and other variables, that correlate with its development and outcomes. Thorough understanding of a disease’s progression is the foundation upon which a clinical development program for drugs, biologics, medical foods, or medical devices is built.¹

Some natural history studies may also have a retrospective aspect, where researches look back on past medical events.

Natural history studies are non-interventional, which means that no therapies or pharmaceutical interventions are involved.

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  1. U.S. Food and Drug Administration. (2018.) Information on the Orphan Products Natural History Grants Program. FDA.gov. Retrieved June 5, 2019 from link.