Perhaps someone more knowledgeable could clarify the following:
- If at the 45% readout (or even the 60%) it is deemed that the treatment is showing outstanding results (as we all expect and hope for ) ie "Overwhelming efficacy" and the decision is made to continue the trial, does it continue with the placebo arm?
- I ask as effectively that would be subjecting those remaining to be enlisted (to complete the trial) with a 50:50 chance of survival (obviously not exactly 50:50 due to improved SOC and Rem-l may not be 100% effective).
- It does raise ethical questions
- Is there any obligation to inform the market (company) or could/would they just announce "the trial is continuing" with out any reference to the results?
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- Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-218
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