Academic Journal
Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making
| Title: | Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making |
|---|---|
| Authors: | Lily Yuan, Motiur Rahman, John Concato |
| Source: | Clinical and Translational Science, Vol 17, Iss 1, Pp n/a-n/a (2024) |
| Publisher Information: | Wiley, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Therapeutics. Pharmacology LCC:Public aspects of medicine |
| Subject Terms: | Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270 |
| More Details: | Abstract 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. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1752-8062 1752-8054 |
| Relation: | https://doaj.org/toc/1752-8054; https://doaj.org/toc/1752-8062 |
| DOI: | 10.1111/cts.13702 |
| Access URL: | https://doaj.org/article/c16aafa860e241c089f236e0b4303578 |
| Accession Number: | edsdoj.16aafa860e241c089f236e0b4303578 |
| Database: | Directory of Open Access Journals |
| Full text is not displayed to guests. | Login for full access. |
| ISSN: | 17528062 17528054 |
|---|---|
| DOI: | 10.1111/cts.13702 |
| Published in: | Clinical and Translational Science |
| Language: | English |