Posted On: 05/03/2016 11:39:26 AM
Post# of 72441
Re: takingabath #22002
Since news on the B-OM front has been pretty quiet as of late I have been wondering about whether or not we are going to get any sort of interim data. I am thinking that the addition of another trial site is about as good of an update as we need right now. My opinion is this is a positive, because why continue to add trial sites and spend more funds if the treatment is not benefiting patients?
That may be over simplistic though. Could it be that adding another site is driven by statistical need, either positive or negative? The positive side: larger patient population and more input to strengthen the data. The negative side: maybe they need a larger patient population because the numbers are weak and they need a larger data set to draw positive statistics from? I don't really think that is the case but I am putting my musings on the board. Anybody have opinions on it?
Either way I do not see adding another site as speeding up the trial, UNLESS the enrollment numbers at the current sites have been declining and they need a minimum number of patients to complete the trial. In that case then it will sure help keep things moving. Leo has stated in past communications that it was a challenge to find patients which met the trial specifications due to the need of not having certain previous treatments which would skew the data for Brilacidin treatment. That's one of the reasons for not performing at MD Anderson if I recall.
That may be over simplistic though. Could it be that adding another site is driven by statistical need, either positive or negative? The positive side: larger patient population and more input to strengthen the data. The negative side: maybe they need a larger patient population because the numbers are weak and they need a larger data set to draw positive statistics from? I don't really think that is the case but I am putting my musings on the board. Anybody have opinions on it?
Either way I do not see adding another site as speeding up the trial, UNLESS the enrollment numbers at the current sites have been declining and they need a minimum number of patients to complete the trial. In that case then it will sure help keep things moving. Leo has stated in past communications that it was a challenge to find patients which met the trial specifications due to the need of not having certain previous treatments which would skew the data for Brilacidin treatment. That's one of the reasons for not performing at MD Anderson if I recall.
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