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Re: exwannabe post# 3723

Monday, 03/10/2008 9:35:24 AM

Monday, March 10, 2008 9:35:24 AM

Post# of 8473
You are missing the risk that one trial center fails to dot its paperwork i's and cross its paperwork t's. You are missing the risk that one trial center fails to do everything possible to ensure that the treated patients return for followup.

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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