OK, now I'm really PO but quite happy the message might finally be getting through, I've been trying to post this since about 16:15
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OK, I'll bang away at this general subject, again
@kervio if this holds true;
" The reason the DSMB is there is to steer the trial without unbinding the results, so if there are factors external to the trial that change how the trial should be designed then they will be factored into the recommendations of the committee and the response from the sponsor."
And the sponsor is the Icahn School of Medicine at Mount Sinai, with Mesoblast listed as Collaborator, the funding is supplied by the NIH for a project aimed ostensibly solely at finding a cure for COVID-19 ARDs, with the funding supplied after the current Public Health Emergency was declared, and it is possible the CTSN supply the DSMB (they have protocols in place for running them), with the CTSN funded by the NIH. Additionally as I've previously stated both the NIH and the FDA are members of the Public Health Emergency Medical Countermeasures Enterprise which was activated before the trial began
Also consider this angle;
From https://www.phe.gov/Preparedness/mcm/phemce/Pages/mission.aspx
Is it possible that the DSMB may also report to the NIH as well as Icahn? Is the sponsor the only party who can close down a trial during a Public Health Emergency if the trial has met pre-defined parameters in relation to the Emergency, that would not normally be considered outstanding efficacy? Just a considerably better survival outcome than currently available, at some pre-defined improvement.
And I note the info with the usual disclaimer, my bold, referred to by @Stickshift FDA guidance (non-binding) to DSMBs
It is a question I do not have an answer to. Perhaps I will ask.
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