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Editorial
. 2023 Sep 11;7(1):e201.
doi: 10.1017/cts.2023.588. eCollection 2023.

Real-world data for 21st-century medicine: The clinical and translational science awards program perspective

Pablo Cure  1 , Sanae ElShourbagy Ferreira  1 , Joshua P Fessel  1 , Deborah Ossip  2   3 , Martin S Zand  2   3   4 , Scott J Steele  2   3 , Kenneth Gersing  1 , Christopher M Hartshorn  1
Affiliations
Editorial

Real-world data for 21st-century medicine: The clinical and translational science awards program perspective

Pablo Cure et al. J Clin Transl Sci. .
No abstract available

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Conflict of interest statement

This work is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the FDA. The findings, knowledge gaps, challenges and opportunities described in this manuscript represent a summary of individual opinions and ideas expressed during the workshop. The summary does not represent any sort of consensus or directive, nor does it represent an expression of research priorities or intended research directions for NCATS or NIH.

Figures

Figure 1.
Figure 1.
Overall data infrastructure, sources, and integration. CMS = centers for medicare & medicaid services claims data; DHT = digital health technologies; EDW = enterprise data warehouse; HER = electronic health records; Labs = laboratory values; X-ray images; RWD = real-world data.
Figure 2.
Figure 2.
Key areas in real-world data within CTSA programs. D&I = dissemination and implementation; FAIR = findable, accessible, interoperable, reproducible; HER = electronic health records; HS = human subjects; PPRL = privacy-preserving record linkages.
See this image and copyright information in PMC

References

    1. FDA. Real-World Evidence: Food and Drug Administration; 2022. [FDA RWE Definitions and Selected Guidance]. Available from: https://www.fda.gov/science-research/science-and-research-special-topics.... Accessed December 22, 2022.
    1. Concato J, Corrigan-Curay J. Real-world evidence - where are we now? New Engl J Med. 2022;386(18):1680–1682. - PubMed
    1. FDA. FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future: Food and Drug Administration; 2022. Available from: https://www.fda.gov/drugs/news-events-human-drugs/fda-issues-draft-guida.... Accessed December 22, 2022.
    1. FDA. Advancing Real-World Evidence Program: Food and Drug Administration 2022. Available from: https://www.fda.gov/drugs/development-resources/advancing-real-world-evi.... Accessed December 22, 2022.
    1. HL7 International. Common Data Models Harmonization - Biomedical Research and Regulation Work Group 2019. Available from: https://build.fhir.org/ig/HL7/cdmh/#guidance-to-the-readers. Accessed December 22, 2022.

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