There are two types of natural history studiesThere are two types of natural history studies: prospective and retrospective. A natural history study examines a group of people who have a specific medical condition or disease or are at risk of developing one. A natural history is non-interventional and collects health information in order to understand how the medical condition or disease develops and how to possibly treat it. No treatment or investigational product is given. In a prospective study, this data collection is forward-looking and is done over time in the future. In a retrospective study, researchers review and examine factors related to an outcome in the past by looking back on past exposures and medical events.: prospective studies 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 researchers 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.