Even more mainstream
A couple weeks ago when I wrote, “Adaptive trials move toward the mainstream” I thought I might have been exaggerating. After all, adaptive trials –which let trials change as they move forward– are still fairly esoteric in the drug world. But maybe I was write. A Wall St. Journal article (FDA Signals It’s Open to Drug Trials That Shift Midcourse) indicates that the FDA is serious enough about adaptive trials that it plans to develop regulatory guidance on them. That could still mean such guidance is several years away from publication and acceptance, but it does mean the agency’s serious.
The Journal article talks about the complexity of design and need for advanced statistical analyses and safeguards, but doesn’t mention Cytel and other firms specifically set up to serve that need.July 10, 2006