Please ignore the last paragraph in my post:
“The only way PRR will be downgraded from 2/3 to 2 is if recruitment is so difficult that the whole thing has to go back to the drawing board – eligibility criteria changed and broadened. This would be big news and would be announced – not changed on the registration site hoping no one notices.”
This is misleading because I got sucked into whole “down-grading” idea.
Canvas 2/3 cannot be downgraded full stop.
Canvas 2/3 may be abandoned because PRR runs out of money or the world ends.
Canvas 2/3 might be stopped because of adverse events occurring during the trial from the intervention.
Canvas 2/3 might not proceed through to the second stage because the results from the interim analysis conducted half way along are not sufficiently strong enough with respect to safety and efficacy to proceed.
Canvas 2/3 might experience difficulties with recruitment, it may go slower than first planned, it might cost more and it may not ultimately to show positive results.
All these bad things can happen – but not “down-grading”.
I’ve learned one thing. Just how easily one’s thinking can get so befuddled from a left field idea on a forum. Taken me a whole half hour to finally wake up to realizing that its just ridiculous. Getting slower by day!
GLTH Southoz.
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