Monday, September 21, 2020 8:00:27 PM
The process goes as follows. Once the 195th patient finishes the 28 day period (which I believe is tomorrow), Amarex (our CRO) unblinds the data and puts together an analyzation report. Once completed, this report is sent to the DSMB. The DSMB will have 2 days to familiarize themselves with the data before the DSMB meeting..
They will then recommend to us one of the following:
- Continue the trial as is
- Recommend a modification
- recommend ending the trial for futility
- recommend stopping the trial as the objectives have been met (efficacy)
We obviously all want them to stop the trial for efficacy. It is rare that this happens as trials are designed with the number of patients that they expect it will take to reach Stat Sig...
The one thing we have going for us is we are in a pandemic. Hopefully this loosens the reigns!!!
(As a side note: Since Amarex is doing the analysis, I don’t see any way possible that they don’t leak the highlights of the results to NP.... just sayin)
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