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Biostatistics

16
Dec
5 min read

Stop the Zombie Trial: The "Kill Switch" for Failed Experiments

The most expensive decision in drug development (or product experimentation) is not starting a trial. It is continuing a zombie trial. Imagine you are at the interim analysis of a Phase II study. You have enrolled 50 of 100 patients. You have spent $10 million. The data is... underwhelming. 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

15
Nov
4 min read

Would You Randomize Before Consent?

Lessons from EDI and Zelen’s Design Dilemma