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Evidence Architecture

11
Dec
3 min read

What BATTLE Got Right That Most Adaptive Trials Get Wrong

Everyone says they want adaptive designs. Almost no one actually runs them. In decks, protocols, and FDA briefing books, “adaptive” has become a fashionable adjective—usually meaning a trial with one interim look, a conditional power calculation, and a long list of things you are not allowed to change. The

09
Dec
3 min read

The Surrogate Trap: When the Mechanism Works But the Patient Dies

In the late 1980s, cardiologists thought they had cracked the code. They knew that patients who developed irregular heartbeats, premature ventricular contractions (PVCs), after a heart attack were more likely to die. They had drugs, encainide and flecainide, that reliably suppressed those irregular beats. The intuition was flawless: Suppress the