FDAnews
www.fdanews.com/articles/63589-pharma-blog-watch

Pharma Blog Watch

November 1, 2006

Adaptive Trials Workshop (Eye on FDA)
In his blog, Mark Senak again brings up the FDA conference on adaptive trials, which "is extremely important because, as FDA has made apparent, adaptive clinical trials are key to the future of personalized medicine and to the FDA's Critical Path Initiative," he writes. "But the concept of this workshop means more than the future development of therapies — it is also an opportunity for FDA to demonstrate its leadership."

But Senak has learned that the conference will not be open to the public, that it will be staged by PhRMA not the FDA and that "that there is also now already allegedly a waiting list," he writes. "How did a waiting list materialize if there is no registration process put forth by either the organizing entity or the federal agency which is the greatest stakeholder? What is going on with this workshop?"