Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence

The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use these data and the associated evidence in decisio...

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Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2020-03, Vol.54 (2), p.303-307
Main Authors: Gliklich, Richard E., Leavy, Michelle B.
Format: Article
Language:English
Subjects:
Criteria
Decision making
Drug Safety and Pharmacovigilance
Evaluation
Expert Commentary
Medicine
Patients
Pharmacotherapy
Pharmacy
Quality assessment
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Summary:The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use these data and the associated evidence in decision making. Patient registries are an important source of real-world data and real-world evidence. The good practices and evaluation criteria developed for patient registries are highly relevant to real-world data and real-world evidence and offer a foundation for a unified set of quality criteria that can be applied across sources of real-world data and real-world evidence intended for use in medical product evaluation.
ISSN:2168-4790
2168-4804
DOI:10.1007/s43441-019-00058-6