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Global Regulators Join Hands To Boost RWE Use In Decision-Making

 
• By Neena Brizmohun

Existing challenges to using real-world evidence such as heterogeneous data sources around the world and the various governance models for data sharing and access will need to be addressed.

Double Exposure Team Teamwork Togetherness Collaboration Concept
Global regulators will work together on using RWE • Source: Alamy

Developing common guidance and best practices for the use of real-world evidence (RWE) is among the four areas that global regulators have pledged to focus on in their collaborative bid to further enable the integration of RWE into regulatory decision-making.

RWE V RWD

Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

Source: US FDA

Ensuring transparency around the use of RWE and real-world data (RWD), and harmonizing the terminologies used for RWE and RWD...

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