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Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-219

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ddwn

12,340 Posts.

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15/10/20

15:26

Post #: 48122005
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Originally posted by nosluggos: ↑

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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No chance of that mate!

If the results are overwhelming - don't worry, this will be shouted!

I don't think the trial can continue as such, but those who have been enrolled may receive Rem-L instead of placebo. This will have to be announced as it is different to the original trial design
MSB Price at posting: $3.23 Sentiment: Buy Disclosure: Held
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