When the Endpoint Moves but the Patient Does Not
- 9 minutes ago
- 1 min read
The endpoint moved. But did the evidence move with it?
A biomarker changes.
A surrogate endpoint improves.
A treatment shows biological activity.
But none of these, on their own, establish that patients feel better, function better, or experience a meaningful change in disease trajectory.
The challenge is that endpoint performance is not fixed.
Disease stage, baseline functional burden, comorbidities, treatment history, and follow-up can all change what the same endpoint actually tells us.
Our latest Evidence Brief examines how these factors shaped the evidence across GRADUATE I and II, EXPEDITION3, and TRILOGY ACS, and asks a more consequential question:
Is the endpoint actually capable of answering the therapeutic question?
The goal is not to explain failed trials in hindsight. It is to understand what the evidence can tell us before confirmatory investment, when there is still time to refine the population, endpoint, follow-up, or therapeutic hypothesis.
Because before Phase III, the question should not simply be whether the endpoint moves.
It should be whether it can tell us who benefits, what that benefit means, when it should emerge, and whether the therapeutic hypothesis deserves to advance.
Read the full Evidence Brief below.
