FDA Weighs Flexibility In Trials of Heart Treatment
September 21, 2007 6:20 AM CT
This NY Times article reports on the September 20, 2007 meeting in which the U.S. Food and Drug Administration heard from a panel of experts about the challenges of conducting atrial fibrillation clinical trials and the need to relax restrictions requiring the comparison of ablations to anti-arrhythmic drug therapy. Companies reported on their difficulty enrolling participants in trials of ablation devices when patients must have first failed with anti-arrhythmia drugs, but if accepted into the trial may find themselves assigned to drugs rather than a procedure. The meeting also discussed the challenges with gathering and interpreting atrial fibrillation treatment data.
As we afib patients know, once you have failed on drugs and are ready for a procedure, drugs become an unacceptable atlernative. No wonder it’s so hard to get the results data we need to make informed decisions.