Thursday, April 18, 2019 6:26:10 AM
After all, AA based on a surrogate that is 'reasonably likely' to do something, is a pretty low bar!
Especially if identifying toxicities prior to approval is optional (as has been the case in all ICI approvals).
You can then have maybe a decade of unfettered access to the market before all toxicities become apparent, and it is discovered that that the 'reasonably likely' benefits don't exist!
So why go to all the bother of testing OS?
You can save yourself a heap of cash and several years of trial duration, by demonstrating something that is reasonably likely to do something that may be of benefit to patients, but usually doesn't..
And forget about bothersome crossover confoundment.
As you say, big trials also help your cause. If you have 10,000 patients, you only need to demonstrate PFS advantage of 6.73 days to have stat sig! (OK, a slight bit of poetic licence employed here..)
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2463590
And things have almost certainly got worse in the 4yrs since Vinay Prasad did that study.
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