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Posted On: 04/15/2020 9:36:46 AM
Post# of 154185
Re: Northstar42 #27708
Northstar,
I don't think yo are wrong at all. The FDA is bannanas !!.
As per my post yesterday, we have more than enough statistical data for a "placebo" arm. These patients are dying and there should be no scientific need for a control arm.
OK. The socioeconomic environment affects the survival rate. That is, if we compare survival from two different hospitals the results will be biased. However, if one has data from many hospitals the reference success probability is a solid, valid number.
Else, FDA con conduct the Leronlimab test in ADVERSE conditions for the drug (hospitals in disadvantaged areas with more comorbidity burden).
No need for control cohort !!. The data is there, and more when the primary outcome is survival (that is, the number that FDA is looking at is simply the success rate, how many Critical patients survive at 14 days). In some trials there is more nuance and more factors need to be taken into account.
I only hope that at 50 patients evaluation the p-number will be so low that FDA will say: enough !!! (before more patients in the control cohort die).
Quote:
Where am I going wrong?
I don't think yo are wrong at all. The FDA is bannanas !!.
As per my post yesterday, we have more than enough statistical data for a "placebo" arm. These patients are dying and there should be no scientific need for a control arm.
OK. The socioeconomic environment affects the survival rate. That is, if we compare survival from two different hospitals the results will be biased. However, if one has data from many hospitals the reference success probability is a solid, valid number.
Else, FDA con conduct the Leronlimab test in ADVERSE conditions for the drug (hospitals in disadvantaged areas with more comorbidity burden).
No need for control cohort !!. The data is there, and more when the primary outcome is survival (that is, the number that FDA is looking at is simply the success rate, how many Critical patients survive at 14 days). In some trials there is more nuance and more factors need to be taken into account.
I only hope that at 50 patients evaluation the p-number will be so low that FDA will say: enough !!! (before more patients in the control cohort die).
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