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 studiesA natural history study that reviews subjects over a forward-looking length of time to observe for outcomes in the development of a disease. and retrospective studiesA natural history study that reviews and examines factors related to an outcome in the past by looking back on past exposures and medical events..
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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- U.S. Food and Drug Administration. (2018). Information on the Orphan Products Natural History Grants Program. FDA.gov. Retrieved June 5, 2019, from link.