The FDA released draft guidance in January 2026 encouraging the use of Bayesian statistics in clinical trials, a shift that could benefit patients with rare diseases like ALS.
Here’s something strange about how we test new drugs: Every clinical trial has to pretend that nothing like it has ever come before.
Even if clinicians have tested similar drugs for years, or if decades of research point in a certain direction, each trial must prove — independently — that the drug works based solely on what happens inside that specific study. Prior knowledge doesn’t count.
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