FDA Provides Advice on Using Real-World Data From Registries

The FDA has issued recommendations for sponsors who are hoping to use real-world data from registries to support regulatory approval of a new drug or biologic.

In a new draft guidance, the FDA defined a registry as “an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition or exposure.”

There are three main types of registries: disease, health services and product. Registries can be used to help inform study design for both clinical trials and observational studies, the agency said, for example by providing information used to help determine sample size, participant selection criteria and clinical endpoints.

Registries may also help pinpoint biomarkers linked to important clinical outcomes when planning a study and may be used to draw inferences about safety and effectiveness ahead of a trial, the agency said.