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Re: highwayman4life post# 97789

Monday, 01/23/2017 4:56:33 PM

Monday, January 23, 2017 4:56:33 PM

Post# of 688522

Can you still obtain approval when a crossover is built into the trail design? YEP



Yes, you can get approval from a trial with x-over.

But, patients who cross are analyzed as part of their originally randomized arm.
Period.
The FDA insists on that. And correctly so.


What might be the reason for THE WHOLE GROUP DOING BETTER? I can think of one common denominator



You are on the right track if you are thinking that they ALL received care at leading research hospitals, ALL had complete or near complete resection often aided by intraoperative MRI, ALL were shown, via MRI, to be stable or better following their primary chemorad, ALL did not require heavy or even moderate doses of steroids, and of course, ALL had to meet special requirements for blood work.

Is that what you were thinking? I hope so. Because if you ignore patient selection factors it's easy to mislead yourself.
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