Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making
Real‐world data (RWD) and real‐world evidence (RWE) are increasingly used to support regulatory decision making, but regulatory agencies and stakeholders may apply different definitions for RWD and use different criteria to determine when analysis of such data are considered RWE in decisions on drug...
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Published in | Clinical and translational science Vol. 17; no. 1; pp. e13702 - n/a |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
United States
John Wiley & Sons, Inc
01.01.2024
John Wiley and Sons Inc Wiley |
Subjects | |
Online Access | Get full text |
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Summary: | Real‐world data (RWD) and real‐world evidence (RWE) are increasingly used to support regulatory decision making, but regulatory agencies and stakeholders may apply different definitions for RWD and use different criteria to determine when analysis of such data are considered RWE in decisions on drug approvals. To explore this issue, we reviewed two prominent publications that operationalized the definitions of RWD and RWE when describing the use of RWE in drug approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Both publications considered noninterventional (observational) studies, RWD as a comparator arm for a single‐arm trial, product‐related literature reviews, and RWD to support clinical trial implementation (e.g., to identify potential participants) as generating RWE. In contrast, inconsistencies were identified regarding types of data sources and study designs that were considered as not generating RWE. For example, a lack of agreement existed regarding whether RWE is generated when RWD describe therapeutic contexts or are used in phase I/II interventional trials, open‐label extension studies, or pharmacovigilance activities. These discrepancies highlight opportunities to develop a consistent understanding of the role of RWE in regulatory decision making for drug approvals among regulatory agencies and stakeholders. |
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Bibliography: | This article reflects the views of the authors and should not be construed to represent the FDA's view or policies. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1 |
ISSN: | 1752-8054 1752-8062 |
DOI: | 10.1111/cts.13702 |