ARTICLE | Regulation

A role for RWE in the accelerated approval pathway

Real-world evidence is poised to make its mark on confirmatory trials

September 1, 2021 1:04 PM UTC

Real-world evidence is still in its infancy, but as its potential becomes increasingly recognized, doors are opening that could render it a difference-maker in the accelerated approval pathway.

In particular, RWE could be key for opening up accelerated approval to more diseases and making confirmatory trials more informative. ...

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