Erika Hamilton, Chief Development Officer, Late Phase and Director, Breast Cancer Research Program at Sarah Cannon Research Institute, shared on LinkedIn:
“Ruxandra Teslo The New York Times essay focuses on Phase 1, and rightly – that’s where the bottleneck is sharpest.
But I want to add the late-phase view, because the same disease shows up downstream and we talk about it less.
One passage will be familiar to anyone who has opened a multi-site trial: the same protocol reviewed by separate ethics boards at different hospitals, on top of the FDA’s own cycle, dragging on for months for procedural reasons – despite NIH having urged single-IRB review for years, and despite no evidence the extra rounds make patients safer.
In a Phase III that is not an administrative footnote. It’s the difference between opening in twenty sites and opening in a hundred. And enrollment is where our system is thinnest: fewer than 5% of US adult cancer patients participate in research, and 20–40% of trials miss enrollment targets.
Here is the reality from the inside: most enrollment failures are designed in, not discovered later.
A lab threshold nobody can hit. A visit schedule that assumes academic-center staffing and a patient that lives 3 miles away.
By the time a protocol is final, the enrollment curve is largely set.
That’s the logic behind Sarah Cannon Research Institute Accelero – protocol feedback and site engagement before the design is set in stone, not after activation stalls, across community research locations where most patients actually receive care.
My ask: make single-IRB review real for multi-site trials rather than aspirational and demand protocol simplification an explicit review expectation.
Ask sponsors to justify each exclusion criterion against the patients it removes.
Rigor and reach are not opposites. We too often act as if they are.”
This Is the Biggest Obstacle to New Cancer Cures
Other articles featuring Erika Hamilton on OncoDaily.