FDA's real-time clinical trials pilot

One reason that clinical trials are slow, expensive, and wasteful is that the data they generate are locked in siloed systems and manually transcribed. Recently, the FDA announced a pilot project to fix this, which would create “Real Time Clinical Trials”. The idea is to let regulators see trial data in real time, as it’s collected, potentially compressing the dead time between study phases. But as Adam Kroetsch writes in a new post, the announcement was muddled; speakers discussed topics like rural access and site burden, which made it unclear what was actually being proposed. His take is that the idea is genuinely promising, but will be difficult to deliver at scale, and requires the FDA to go much further. He recommends they define how they actually use live data, build interoperability standards, and give sponsors explicit regulatory cover to abandon unnecessary verification practices.