HealthIT Answers January 21, 2024
Robert M. Califf, M.D.

What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.

Related, 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. I’d like to catch up with you today on some of the challenges and advancements in RWD and RWE.

Understanding RWD, RWE and Challenges in the Ecosystem

It’s important to understand that RWD relate to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic...

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