By Published On: December 13th, 2019Categories: News

A ‘Registry’ is the same as a ‘Registry Study’…Right? Wrong!

We often use the terms ‘registry’ and ‘registry study’ to mean the same thing. But they are actually different.

According to the EMA, a patient registry is a long-term, open-ended data collection system that uses observational methods to collect data on a patient population. The type of data (real world data) collected in a patient registry is defined by a particular disease, drug exposure or condition (e.g. age, pregnancy, specific patient characteristics). Whereas, a registry study seeks to answer a specific research question and parameters such as duration, patient population, data to be collected (and analysis to be performed) are defined (and constrained) by a study-specific protocol. The data collected in a registry may be used for the purpose of a specific study (EMA/763513/2018).

The EMA even acknowledges that regulators have sometimes requested marketing authorisation holders (MAHs) to establish a registry, although the objective was to perform a registry study e.g., a post-authorisation safety study (PASS) to monitor the safety of a product (EMA/763513/2018).

The distinction is important because the regulatory, methodological, operational and quality considerations can differ significantly between a registry and a registry study.

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