Saloni Dattani (@salonium): "Great post by @Adam Kroetsch on the FDA’s recent announcement of “real time clinical trials”. The idea of streamlining data collection and review sounds very promising in theory, but he argues the FDA needs to go beyond pilots to actually change practice, and shares some recomm…"

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Great post by Adam Kroetsch on the FDA’s recent announcement of “real time clinical trials”.

The idea of streamlining data collection and review sounds very promising in theory, but he argues the FDA needs to go beyond pilots to actually change practice, and shares some recommendations for how they can do so.

As excited as I am about the potential of this new approach to running trials, the initial rollout was not exactly confidence inspiring. The FDA didn’t really tell a coherent story about why real-time trials matter, how the agency intends to use the data, or what it will take to scale up this work. But there’s still plenty of time for the FDA to provide more clarity

Adam Kroetsch

May 11

9:51 PM

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