Disease Registries
EU: EMA Use of Patient Disease Registries for Regulatory Purposes – Disease registries are patient registries where entry is determined by the diagnosis of a disease (as per Section 3.2 of EMA – Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, Nov 2018)
Patient disease registries are often created by public organisations such as academia or medical research associations of health care professionals or patients. They may have different objectives, such as to describe the natural history of a disorder, to monitor the efficacy or safety of treatments, for example in subpopulations (e.g. geriatric patients) for which pre-authorisation data are limited, to describe the impact of a disease on patients’ health and quality of life or to identify patients suitable for new treatments. Irrespective of the original aim pursued by the registry, the data collected may also be useful to support the regulatory evaluation of benefits and risks of medicines. For this reason, regulators generally prefer disease registries, i.e. patient registries where entry is determined by the diagnosis of a disease, to product registries, i.e. patient registries where entry is determined by the prescription of a specific drug, as disease registries gather insights on clinical outcomes of conditions in patients receiving different treatments, rather than on the outcomes of a specific treatment, and they may support a wider range of study designs, e.g. controlled designs without an external data source. They are also generally better integrated into health care systems and are therefore more likely to be sustainable and provide long-term follow-up data on patients (as per Section 3.2 of EMA – Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, Nov 2018)
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