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jbainseky

07/23/14 5:49 AM

#183897 RE: Protector #183895

CP - the only problem with your timeline is we expect those on BAVI to live 12+ months, so some won't have evented in the 7.5 months, and you would have needed everyone who was enrolled by June 14 to have evented in order to reach the 100 events. I hope they have more people enrolled by now, but that is why I'm in the 6-10 month range. not to mention the time to evaluate the data. I think early in 2015.

JBAIN

ImaPseudonym

07/23/14 7:28 AM

#183902 RE: Protector #183895

Personally, I doubt that it would be stopped so soon. It is important to keep in mind that the more times that a data monitoring committee plans to look at the data to make stop/keep going decision, the higher the target p-value has to be to count as a success.

As an example, suppose that you are testing avastin against avastin (in other words, there is no difference between the control and experimental group). If your target is a p<.05 then every time you look at the data and run the numbers there is a 1 in 20 chance of finding that the experimental group is stat sig better than the control. So suppose you plan to look at the data 20 times while it is accruing, then you are virtually guaranteed to "discover" that Avasting is better than itself and that this superiority meets the threshold for stat sig.

This is why when conducting multiple interim looks, it is essential to use a more stringent threshold than .05 for statistical significance.