Stat guys .. What do you think of this ?? The a
Post# of 153863
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Posted On: 07/22/2020 4:24:49 PM
Stat guys .. What do you think of this ??
The actual analysis is remedial. You code each of the outcomes 0-3 and then get a total score. This occurs at baseline and Day 14. The dependent variable (outcome) of the statistical analysis is Day 14 Score - Day 1 Score (baseline). This is a bit of a tough statistical outcome, you can imagine that scores at baseline for mild subjects will be 1-4. Post-baseline, they can be 0-12. A change from 1-4 to 0 could be "problematic" depending on the model. The protocol/SAP might have categorized the changes. Regardless, they have that analyses completed, assuming that they are not cleaning the data on the four conditions. I would not be surprised if they needed to clean because the speed at which they enroll and completed was FAST. I assume the CYDY is holding to complete the other (secondary) analyses, which is concerning, not because of the science, but because it is in the framework of a clinical trial, which honors the PRIMARY outcome. I might have pushed back on a 0-12 score and I have experienced the very issue of milds going from a low score to a hard bottom of 0. If a mild goes from say 3 to 1 in the Leronlimab group, but a moderate goes from 7 to 3 in the placebo group, what can we conclude? Yeah, that is a tough statistical outcome...
The actual analysis is remedial. You code each of the outcomes 0-3 and then get a total score. This occurs at baseline and Day 14. The dependent variable (outcome) of the statistical analysis is Day 14 Score - Day 1 Score (baseline). This is a bit of a tough statistical outcome, you can imagine that scores at baseline for mild subjects will be 1-4. Post-baseline, they can be 0-12. A change from 1-4 to 0 could be "problematic" depending on the model. The protocol/SAP might have categorized the changes. Regardless, they have that analyses completed, assuming that they are not cleaning the data on the four conditions. I would not be surprised if they needed to clean because the speed at which they enroll and completed was FAST. I assume the CYDY is holding to complete the other (secondary) analyses, which is concerning, not because of the science, but because it is in the framework of a clinical trial, which honors the PRIMARY outcome. I might have pushed back on a 0-12 score and I have experienced the very issue of milds going from a low score to a hard bottom of 0. If a mild goes from say 3 to 1 in the Leronlimab group, but a moderate goes from 7 to 3 in the placebo group, what can we conclude? Yeah, that is a tough statistical outcome...
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