A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
CONSONANCE's digitally enhanced MS endpoint cut required sample size 24.9%. Here's what that number costs in protocol amendments, IRB...
protocol amendments
When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
The Protocol That Ate the Timeline: How Scope Creep Becomes a Site Operations Crisis
76% of trials now require protocol amendments—and every one resets IRB clocks, contract cycles, and site activation timelines your...