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Saturday, May 02, 2020 12:28:34 PM
They say in the article that the researchers did not know results when they made the change but they knew how many had died in total and they therefore knew their endpoint (deaths) wasn’t going to be “statistically significant” so it appears they really did know.
They wouldn't even have to know the death rate. Gilead had results from it's 5/10 day dosing trial and the China trial and knew how awful it was performing.
NIAID said in response to questions Thursday that it made the switch eight weeks later to the more limited measure of “time to recovery'' based on modeling that took into account new information about the course of the disease. The initial measurement period of two weeks, it said, was deemed to be too short as scientists learned more about the lengthy time patients could be seriously ill with covid-19, NIAID said.
Which only answers why the length of the trial changed not the primary endpoint. What of those who went to critical and had not recovered by 29 days? They must have not have been counted in the time to recovery. With the side effects of remdesivir was there a higher percentage in that category with remdesivir than placebo and did that skew the results?
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