There has been some discussion about the number of
Post# of 154837
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Posted On: 06/03/2020 4:26:06 PM
There has been some discussion about the number of patients in the Ph2 mild to moderate trial, and whether or not unblinding early would have a significant impact on the statistical probabilities.
I got to thinking, I wonder if the format of the trial and the metrics has any bearing on the statistical strength (p value)
PRIMARY OUTCOME MEASURE
Clinical improvement by change in total symptom score
SECONDARY OUTCOME MEASURES
1. Time to clinical resolution
2. Change from baseline in NEWS2
3. Change from baseline in pulse oxygen saturation
4. Change in baseline in the patients health status on a 7 category scale
5. Incidence of hospitalization
6. Duration of hospitalization
7. Incidence of mechanical ventilation
8. Duration of mechanical ventilation
9. Incidence of oxygen use
10. Duration of oxygen use
11. Mortality rate
12. Time to return to normal activity
OTHER OUTCOME MEASURES:
1. Change in size of lesion area by chest radiograph or CT
2. Change from baseline in serum cytokine occupancy levels
3. Change from baseline in CCR5 receptor occupancy levels
4. Change from baseline in CD3+, CD4+ and CD8+ T cell counts.
In other words, as compared to the severe trial which has a binary outcome (mortality), does the 17 different measurements for each patient help to create more statistical strength which may offset the small patient sample?
I got to thinking, I wonder if the format of the trial and the metrics has any bearing on the statistical strength (p value)
PRIMARY OUTCOME MEASURE
Clinical improvement by change in total symptom score
SECONDARY OUTCOME MEASURES
1. Time to clinical resolution
2. Change from baseline in NEWS2
3. Change from baseline in pulse oxygen saturation
4. Change in baseline in the patients health status on a 7 category scale
5. Incidence of hospitalization
6. Duration of hospitalization
7. Incidence of mechanical ventilation
8. Duration of mechanical ventilation
9. Incidence of oxygen use
10. Duration of oxygen use
11. Mortality rate
12. Time to return to normal activity
OTHER OUTCOME MEASURES:
1. Change in size of lesion area by chest radiograph or CT
2. Change from baseline in serum cytokine occupancy levels
3. Change from baseline in CCR5 receptor occupancy levels
4. Change from baseline in CD3+, CD4+ and CD8+ T cell counts.
In other words, as compared to the severe trial which has a binary outcome (mortality), does the 17 different measurements for each patient help to create more statistical strength which may offset the small patient sample?
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