Monday, March 10, 2008 9:35:24 AM
I am almost certain that there was a company that recently had its drug not approved because one trial center failed to have its paperwork in order. I think I recall that the FDA zeroed out all patients which meant that placebos were treated as if they had not declined and active controls were treated as if they had no improvement. The end result was moving the trial results from positive to negative.
In a small trial every thing, every patient takes on added significance.
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