Nature May 5, 2023
Real-world data reflect the diversity and lived experiences of individuals and so should be a central pillar of clinical research and care.
The key to the value of RWD will be scientific consensus about how to rigorously analyze and draw conclusions from what are currently novel data sources. This consensus is developing steadily, driven in large part by scientific guidance from regulatory authorities. Since 2021, a stream of guidance documents has outlined the US Food and Drug Administration (FDA) thinking on crucial scientific issues...
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