So, I think they were thinking 1st lookin is very early and making sure we are not getting screwed by anybody.
That doesn't make sense. PPHM will not see any data from the first look so they won't be able to tell anything about tampering. The only ones that will see the data are the members of the DMC.
The reason that the FDA requires trials to have an early look for safety is so enrollment can be stopped and the number of patients at risk can be minimized. In the event that the FDA is only concerned with safety on the first look, this interim look would be based on a predetermined number of enrolled patients. This would be a relatively small number, in this case say around 100, in order to limit the risks. If the FDA isn't that concerned with safety, then the first look could be based on a predetermined number of deaths and that would allow for a look at both safety and efficacy.
Most trials of this type that run all the way to the end are stopped when 80% of the intent to treat patients have died. Generally, at that point a trial would be deemed successful if they get a HR of 0.8 or lower with a P value of 0.05 or lower. Lets say for the Sunrise trial that the FDA agrees to have the first interim analysis look at both safety and efficacy. It would seem likely that this would come at around 200 deaths or about 35% of the 582 patients enrolled in the trial. For this first look with 200 events the required HR to get the trial stopped will not be 0.8 and the P value will not be 0.05. Those numbers will be much lower. More like 0.6 for the HR and 0.002 for the P value. It's basically set up so that they will need very special results in order to stop the trial at that early stage. Also, I get the impression that because of the reconstructed phase 2 results, the FDA has made those numbers unattainable in order so they can see the results from a larger group of patients.
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