(Total Views: 1079)
Posted On: 10/06/2020 7:46:27 AM
Post# of 155739
As we anxiously await the results from the interim analysis (if they are made public) the important number is how many deaths occurred in the Leronlimab arm. Period.
What we know:
Total number of patients of trial: 195
Patients dosed with Leronlimab: 130
Patients treated with with SOC: 65
Number of deaths: 45
The question is: how many deaths can we "afford" in Leronlimab's group before we could be considered for trial stoppage for efficacy ???
There is no real answer as we are in a Pandemic and it is up to the FDA to make that decision. Different criteria apply and we are not BP.
In my opinion (and ONLY my opinion), we have a good chance of having the trial stopped if we have a maximum of 23 deaths (22 deaths in the Placebo group). The FDA would have a very hard time continuing the trial with this kind of numbers.
Also, if we are close to this range we will not have a difficult time demonstrating effectiveness if FDA decides the trial has to go to full enrollment (meaning we are border-line for interim as the trial power is lower at this stage). Of course, if the opposite is true (more deaths in our cohort), we will have hard time achieving statistical efficacy at the end.
So, this is it, the rubber has hit the road, and let’s hope we can help patients with COVID in S/C condition !!!
As Dr. Patterson once said:
Good Luck to YOU All !!!
What we know:
Total number of patients of trial: 195
Patients dosed with Leronlimab: 130
Patients treated with with SOC: 65
Number of deaths: 45
The question is: how many deaths can we "afford" in Leronlimab's group before we could be considered for trial stoppage for efficacy ???
There is no real answer as we are in a Pandemic and it is up to the FDA to make that decision. Different criteria apply and we are not BP.
In my opinion (and ONLY my opinion), we have a good chance of having the trial stopped if we have a maximum of 23 deaths (22 deaths in the Placebo group). The FDA would have a very hard time continuing the trial with this kind of numbers.
Also, if we are close to this range we will not have a difficult time demonstrating effectiveness if FDA decides the trial has to go to full enrollment (meaning we are border-line for interim as the trial power is lower at this stage). Of course, if the opposite is true (more deaths in our cohort), we will have hard time achieving statistical efficacy at the end.
So, this is it, the rubber has hit the road, and let’s hope we can help patients with COVID in S/C condition !!!
As Dr. Patterson once said:
Quote:
We will soon find out where we stand in the COVID world
Good Luck to YOU All !!!
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