questions re phase 3 trial, page-9

Hi Roger,

I don't believe there is any reason we should assume that the selection criteria for these patients would differ, particularly when announcements have stated (as quoted by Mrdog above) that these patients would be included in primary outcome analyses to increase statistical power.

To be realistic, it would actually be very difficult for them to have coordinated such a rapid change in patient selection criteria across numerous sites in multiple countries. Consider all of the oncologists, surgeons, nurses, secretaries etc. you would need to re-educate as to the enrollment criteria, and the high likelihood for every single hospital involved to request an ammended ethics application (including committee review processes which can take months on their own), and potential requirement for independent reviewer committee meetings, etc. on any alteration to patient inclusion critera.

Now, I'm not saying it didn't happen, but I wouldn't consider it to be very likely - particularly when you consider that the patients initially selection for recruitment are exactly the type of patients for whom we are interested in the safety profile data anyway. To modify the selection criteria would simply serve to unnecessarily muddy the waters, while soaking up valuable time and resources.

Hope this helps.