Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making. Article Swipe
Meredith Zozus
,
Byeong Yeob Choi
,
Maryam Y. Garza
,
Rhonda Facile
,
Holly J. Lanham
,
Zhan Wang
,
Bill Sanns
,
Muayad Maallah
,
Henry Wei
,
A. Cramer
,
Eric L. Eisenstein
·
YOU?
·
· 2023
· Open Access
·
YOU?
·
· 2023
· Open Access
·
The 21st Century Cures Act allows the US Food and Drug Administration to consider real world data (RWD) for new indications or post approval study requirements. However, there is limited guidance as to the relative quality of different RWD types. The ACE-RWD program will compare the quality of EHR clinical data, EHR billing data, and linked healthcare claims data to traditional clinical trial data collection methods. ACE-RWD is being conducted alongside 5-10 ancillary studies, with five sponsors, across multiple therapeutic areas. Each ancillary study will be conducted after or in parallel with its parent clinical study at a minimum of two clinical sites. Although not required, it is anticipated that EHR clinical and EHR billing data will be obtained via EHR-to-eCRF mechanisms that are based on the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard.
Related Topics
Concepts
Interoperability
Clinical trial
Quality (philosophy)
Data collection
Data quality
Real world data
Food and drug administration
Health care
Computer science
Medicine
Data mining
Data science
Process management
Business
Risk analysis (engineering)
World Wide Web
Philosophy
Metric (unit)
Pathology
Statistics
Economics
Epistemology
Marketing
Economic growth
Mathematics
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://pubmed.ncbi.nlm.nih.gov/37350921
- OA Status
- green
- Cited By
- 3
- References
- 25
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4381716632
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4381716632Canonical identifier for this work in OpenAlex
- Title
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Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making.Work title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
-
2023-01-01Full publication date if available
- Authors
-
Meredith Zozus, Byeong Yeob Choi, Maryam Y. Garza, Rhonda Facile, Holly J. Lanham, Zhan Wang, Bill Sanns, Muayad Maallah, Henry Wei, A. Cramer, Eric L. EisensteinList of authors in order
- Landing page
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https://pubmed.ncbi.nlm.nih.gov/37350921Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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greenOpen access status per OpenAlex
- OA URL
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https://pmc.ncbi.nlm.nih.gov/articles/PMC10283122/pdf/2052.pdfDirect OA link when available
- Concepts
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Interoperability, Clinical trial, Quality (philosophy), Data collection, Data quality, Real world data, Food and drug administration, Health care, Computer science, Medicine, Data mining, Data science, Process management, Business, Risk analysis (engineering), World Wide Web, Philosophy, Metric (unit), Pathology, Statistics, Economics, Epistemology, Marketing, Economic growth, MathematicsTop concepts (fields/topics) attached by OpenAlex
- Cited by
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3Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1, 2024: 2Per-year citation counts (last 5 years)
- References (count)
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25Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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