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Re: flipper44 post# 5004

Thursday, 02/27/2014 5:13:36 PM

Thursday, February 27, 2014 5:13:36 PM

Post# of 704253
Think this through just a little further. The events are not happening as quickly as even the company suspected. Thus safety can be evaluated to some degree without unblinding the data for a quick peak. Thus they can stick to the blinded trial, which means they will not compare treated to untreated patients except at predesignated interim looks.

The DMC can't say, "hey Joe, let's get 5 more events, unblind 'em, throw them in the statistical hopper with the others and see if separation is looking better or worse."

That is exactly what the entire field of statistical sequential analysis was meant to avoid because it creates the possibility for Type ! or Type 2 error. This is why the trial has predesignated DMC analysis points.

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