In theory so easy to check as they must have full prior treatment history of all participants even if it wasn't a specific exclusion.
If that were the case then USA, Australia will have been the geographic region with the poor PFS and being 1st world medical system should be easy to retrieve data from patients / oncologists even if it wasn't initially aquired
Yes I get it that it doesn't instantly change our locked trial and nothing will get it over the line but it sure would make some sense and leave a pathway forward depending on recalculated PFS with that exclusion but possibly a very low powered result . Would add instant value back to the platform.
Anyone have any idea how many of the 76 centers were in USA , Australia or countries with Avastin 1st line as a option and any clue as to how many participants were from those centers?. These numbers may be meaningless especially if there has been Avastin trials in other geographic regions and those participants have then gone onto our trial as a second line since they are already in the system?
Off to read the patient requirements again.
Does anyone know if that exclusion was to result in a very significant change to PFS if there is a short cut with FDA to open up the study and repower it or is it a start from scratch?
Anyone know of a study avastin 1st line and folfiri 2nd line so we could have a idea of PFS could be?
With this being blinding obvious I wonder if ACL ever looked at this as a prospect in the lab even after the trial started? It is not like they have sat on their hands so must have significant data on many treatment regimens
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