Friday, September 11, 2020 9:15:00 PM
Randy The danger in having a drug available thru compassionate use ...is everyone in the ICU for Covid , wants the drug and no one wants the risk of getting the placebo.
These are tough decisions ...to enroll the trial fast U may need to tell patients who enroll in the trial ...that if they worsen to the degree of needing ECMO ...they would get RLF-100 as last chance compassionate use if they were determined to have been on the placebo in the trial.
Just speculating here .
If they were enrolling fast they might elect to skip ( with DMC permission ) the Interim 2 . Having to many interims reduces the power in the trial ...so to maintain power ...ie better chance of showing stat sig results . ( very simple explanation as I don't remember enough on how interims affect powering ) .
Bottom line ...we need a PR stating the IV trial is fully enrolled
Kiwi
These are tough decisions ...to enroll the trial fast U may need to tell patients who enroll in the trial ...that if they worsen to the degree of needing ECMO ...they would get RLF-100 as last chance compassionate use if they were determined to have been on the placebo in the trial.
Just speculating here .
If they were enrolling fast they might elect to skip ( with DMC permission ) the Interim 2 . Having to many interims reduces the power in the trial ...so to maintain power ...ie better chance of showing stat sig results . ( very simple explanation as I don't remember enough on how interims affect powering ) .
Bottom line ...we need a PR stating the IV trial is fully enrolled
Kiwi
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