Natural history study

In medicine, a natural history study is a study that follows a group of people over time who have, or are at risk of developing, a specific medical condition or disease. A natural history study collects health information over time in order to understand how the medical condition or disease develops and to give insight into how it might be treated.

A natural history study is often submitted when applying to the FDA or another regulatory agency as a baseline to show the agency the disease course for untreated patients. The natural history data is compared to the disease course of patients given the proposed therapy to show how the natural progress is changed or perhaps halted by the therapy.