(Total Views: 579)
Posted On: 10/23/2020 8:13:50 PM
Post# of 154119
I still continue to be confused by this scenario.
I was under the assumption that the DSMC would halt the trial if efficacy and statistically significant data were present at the time of the interim analysis. They didn’t recommend to halt the trial, so I assumed the data was not statistically significant, but trending in the right direction as they recommend the trial to continue as is (with a request to review mortality at 42 days). The addition of the 42 day mortality rate makes me think that mortality is better at 42 days and may be more statistically significant at the 293 mark compared to 28 days.
With all that being said, I don’t see how unblinding now would benefit CYDY if the data isn’t statically significant (based on assumptions of what we know).
Is it possible a regulator agency would assist in increasing enrollment if they realized a reduction of 35-45% in mortality will likely be significant at 293 of 390? Is that what the idea is?
I was under the assumption that the DSMC would halt the trial if efficacy and statistically significant data were present at the time of the interim analysis. They didn’t recommend to halt the trial, so I assumed the data was not statistically significant, but trending in the right direction as they recommend the trial to continue as is (with a request to review mortality at 42 days). The addition of the 42 day mortality rate makes me think that mortality is better at 42 days and may be more statistically significant at the 293 mark compared to 28 days.
With all that being said, I don’t see how unblinding now would benefit CYDY if the data isn’t statically significant (based on assumptions of what we know).
Is it possible a regulator agency would assist in increasing enrollment if they realized a reduction of 35-45% in mortality will likely be significant at 293 of 390? Is that what the idea is?
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