pphmtoolong, I see what you say.
But there is a BUT. For the opening of the centres everybody can understand that their are some practical reasons why they cannot be opened at the same time. International protocols and authorisations, contract with all centres, different languages as we say from the Italian and the Greek protocols we found, training in different countries or fly-ins, etc, etc, etc. And when a few centres are open the CRO will tune its working methods and there we go. So there is the hockey stick.
However, all centres that opened new way UPFRONT that they would participate in SUNRISE. We know that from the protocol dates. And so the people involved at that centre could anticipate SUNRISE on their menu of choices.
So if now we come back to your assumption, slow the first 12 months and then 40 a month during 6 months (I know this was an example and not intended as EXACT numbers) then we are back in the non-linearity of the enrolment PER CENTER. And I have had this discussion with jbainseky and I will tell you the same thing:
WHAT WOULD BE THE RATIONAL THAT ALLOWS TO EXPLAIN ANOTHER THEN NON-LINEAR ENROLMENT CURVE?
Unless PPHM said, "guys, no more then 1 patient every 4 months to start till JUN and then go for it" OK then you would have a RULE that explains non-linear enrolment. If there would be any other situation that would result in MEANINGFUL non-linear enrolment I'll be happy to consider it. But for now, non was ever given beside the statements that "IT COULD BE" . Yes it could be but for now there is no indication that instructions to slow down enrolment or elements that would slow down enrolment in the beginning (e.g. 12 months) exist.
And with the word meaningful I mean situations as in your example and not intra-3 months periods because in simulations such variations show a linear out-come due to the way they are presented.
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