Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.
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DOI: 10.1007/s40264-019-00862-x
Abstract: IntroductionPatient registries, 'organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time', are potentially valuable sources of data… read more here.
Keywords: regulatory assessments; increasing use; patient registries; registry ... See more keywords
Factors Influencing the Generation of Evidence from Simple Data Held in International Rare Disease Patient Registries
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DOI: 10.1007/s40290-019-00316-w
Abstract: Background Rare diseases (defined as affecting  read more here.
Keywords: patient registries; rare disease; disease; evidence ... See more keywords
Ethics practices associated with reusing health data: an assessment of patient registries
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DOI: 10.1186/s12916-024-03799-w
Abstract: As routinely collected patient data have become increasingly accessible over the years, more attention has been directed at the ethics of using such data for research. Patient data is often available to researchers through patient… read more here.
Keywords: information; health data; patient registries; ethics practices ... See more keywords
Rare Disease Registries Are Key to Evidence-Based Personalized Medicine: Highlighting the European Experience
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DOI: 10.3389/fendo.2022.832063
Abstract: Rare diseases, such as inherited metabolic diseases, have been identified as a health priority within the European Union more than 20 years ago and have become an integral part of EU health programs and European… read more here.
Keywords: patient registries; rare disease; disease; evidence ... See more keywords
Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
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DOI: 10.3389/fphar.2022.924648
Abstract: Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment, study design and little knowledge… read more here.
Keywords: patient registries; registries regulatory; medicinal products; contribution patient ... See more keywords