Sign in Subscribe

Trial Design

15
Nov
4 min read

Would You Randomize Before Consent?

Lessons from EDI and Zelen’s Design Dilemma Imagine reviewing a clinical trial protocol that randomizes patients before asking for consent. Patients assigned to the control arm will receive nothing beyond standard care, so they will never be contacted. Only those randomized to the intervention will be informed that a

10
Nov
4 min read

When the p-value Was Enough: Rethinking Trial Design Through ISIS-2

A simple trial. A massive effect. A p-value so small it barely needed confidence intervals. In 1988, ISIS‑2 didn’t just change cardiology—it proved that 162 mg of aspirin could prevent one in every forty deaths after acute myocardial infarction. More importantly, it reminded statisticians what clinical trial