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Posted On: 05/06/2020 8:44:37 AM
Post# of 148890
Back to the numbers.
Is this meaningful from the statistical perspective?
If we use a mortality rate of 0.88 and we had a survival of 6 patients (as per our paper), we have a p number of 0.0004 (yes, 3 zeroes).
The minimun number of patients for statistical significance is 4 (p=0.0239) meaning that if this was a trial (enough number of patients) roughly if we saved at least 4 of each 10 patients we will have approval.
Richardson paper mentions:
OK. Lets asume that we will be compared with 18 to 65 years old patients:
Saving 6 patients will yield a p-number of 0.0148 still will be approved !!! (even comparing our results with the very ill and older Montefiory patients against younger patients in the same New York general area).
Needles to say for 97.2% we will be having a number way above statistical significance.
This data is very meaningful as what we can expect for the Severe trial.
We are in extremely good shape
Quote:
Ten critical COVID-19 patients at the Montefiore Medical Center received leronlimab via FDA-approved emergency investigational new drug (EIND) requests for individual patient use. These confirmed SARS-CoV-2 positive patients had significant pre-existing co-morbidities and were receiving intensive care treatment including mechanical ventilation or supplemental oxygen for ARDS. Consistent with previous reports of severe COVID-19 disease2, these patients showed evidence of lymphopenia with liver and kidney damage. Four of the patients died during the fourteen day study period due to a combination of disease complications and severe constraints on medical equipment culminating in medical triage. Although this EIND study lacks a placebo control group for comparison, a recent study of other critically ill COVID-19 patients in the New York City area indicates mortality rates as high as 88%.
Is this meaningful from the statistical perspective?
If we use a mortality rate of 0.88 and we had a survival of 6 patients (as per our paper), we have a p number of 0.0004 (yes, 3 zeroes).
The minimun number of patients for statistical significance is 4 (p=0.0239) meaning that if this was a trial (enough number of patients) roughly if we saved at least 4 of each 10 patients we will have approval.
Richardson paper mentions:
Quote:
Mortality rates for those who received mechanical ventilation in
the 18-to-65 and older-than-65 age groups were 76.4% and
97.2%, respectively.
OK. Lets asume that we will be compared with 18 to 65 years old patients:
Saving 6 patients will yield a p-number of 0.0148 still will be approved !!! (even comparing our results with the very ill and older Montefiory patients against younger patients in the same New York general area).
Needles to say for 97.2% we will be having a number way above statistical significance.
This data is very meaningful as what we can expect for the Severe trial.
We are in extremely good shape
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