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Re: attilathehunt post# 364251

Friday, 07/02/2021 10:59:05 PM

Friday, July 02, 2021 10:59:05 PM

Post# of 405179
For better or worse IPIX designed and the FDA approved the trial to include patient status at day 60 for all participants.
I believe (which counts for damn little) that that needs to be adhered to unless...
1. The trial needs to be stopped for safety reasons or
2. Interim results are so positive that it would be unethical to deprive the placebo treated participants the opportunity to benefit from the drug.
(I guess they would re-treat the placebo patients.)

The problem is that some feel that the blinding of the trial precludes the DMC from having an awareness of the results to date such that they can't make such a recommendation. I don't believe (still worth diddly) that's true.
Sometimes such decisions are considered at the time of a planned interim study, but I don't think that's ALL of the time. The DMC can see the data whenever they choose (let's see how much flak that draws) so surprising results can get the DMC's attention.

I'm tryin ta think but nuttin happens......Curly

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