White Paper

Registry & Natural History Studies: Vital, Contrasting Roles


“Registry and natural history studies are used interchangeably, but they are not the same, and it is important to understand the differences.”  — Juliet Moritz, Premier Research Vice President, Patient and Stakeholder Engagement (PASE)

For example, patient registries are generally unrestricted in their goals and can be set up to collect any set of data. While natural history studies, by comparison, have a very specific goal: to track a disease’s course over time by identifying factors such as demographics, environmental conditions, and genetic variables that correlate to the disease and its outcomes. And, according to the FDA, one potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging.

Learn more about the nuances and unique challenges between patient registries and natural history studies.