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May 28, 2024

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Advancing Regulatory Science Through Real-world Data and Real-world Evidence Editorial Published in Journal of Clinical and Translational Science

An editorial on real-world data and real-world evidence was recently published in the Journal of Clinical and Translational Science. Authors include Pablo Cure, Joshua P. Fessel, Christopher M. Hartshorn of NCATS and Scott J. Steele of CTSA hub the University of Rochester Medical Center. Please see below for an excerpt and details to view the editorial and thematic issue.

 

Background and overarching categories for thematic issue

This special-themed issue of the Journal of Clinical and Translational Science will focus on the use of diverse sources of Real-World Data (RWD) and Real-World Evidence (RWE) to Advance Translational Science. The goal is to highlight research, activities, and processes for the translation of RWD from a range of sources into RWE that can enhance the full translational science continuum, ultimately improving the development, approval, adoption, and use of safe and effective medical products.

 

The manuscripts in this thematic issue have been written for a broad target audience of all those engaged in clinical and translational science. Manuscripts addressing the spectrum of sources and applications of RWD/RWE in translational science were considered, with the following being of particular interest: use of electronic health records, registries, claims data and other data sources to generate RWE; opportunities and challenges for Digital Health Technologies to generate RWE; evolution of novel methods to accelerate the generation and use of RWD/RWE; policy considerations for the use of RWD/RWE; use of RWD/RWE to improve clinical trials trial designs; data access, use, sharing and fit-for-purpose considerations; emerging use cases for RWD/RWE in translational science; infrastructure to support the generation and; use of RWD/RWE in translational science…

 

Read the full editorial here.

View the full thematic issue of the Journal of Clinical and Translational Science here.

 

If you have questions regarding the editorial and thematic issue, please email Pablo Cure at pablo.cure@nih.gov.

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Coordination, Communication, and Operations Support (CCOS) is funded by theNational Center for Advancing Translational Sciences, National Institutes of Health.

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