© BRYAN SATALINOIt’s a moment every clinical researcher dreads: you crunch the numbers for an upcoming trial and realize you’ll need to recruit tens of thousands of participants to show a statistically significant effect for the therapy you’re testing. You don’t see any way to change most of your variables linked to trial size. But what if you change your endpoints?
In recent years, a growing number of clinical trials have used composite endpoints—multiple events all treated as one endpoint—as a way to boost the power of a study so that fewer participants are needed. “Say you’re designing a study to look at heart attacks, and it looks like you’ll need 40,000 patients,” says Joshua Stolker, a cardiologist at Mercy Clinic in Saint Louis. “But if you use a combined endpoint that considers both heart attacks and hospitalizations, suddenly you only need 20,000. Then you add in revascularization surgeries, and you only need 5,000 patients.”
In that hypothetical example, researchers who chose to combine all three outcomes would be testing whether their intervention changed the number of heart attacks patients experienced, the number of hospitalizations, or ...
