What to do instead of UPSIs On December 22, 2025, Dr. Hackman published a guide to guaranteeing significant results. If cheating at science is your goal, he says, it’s required reading. I spent nearly a decade writing SAPs designed to prevent exactly this. The 92% false positive rate he
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
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
