Tuesday, July 16, 2024 11:55:06 AM
If individual patient-level data was a absolute FDA requirement for ECA then no lethal cancer drug trial could be run ever again.
Looks to me like plenty of cancer trials are being run and we have yet to see one with an approval based on summary level ECA data. Kind of ridiculous for you to say something that is normal is impossible.
Why are you convinced LL is an idiot when she bemoans this issue and wishes there was a way to make data more available?
Also in the treatment arm every patient must be 100% identical
That is not what individual patient level data means. And not what "matched" means. Just because you do not understand the basic language here does not mean the FDA does not.
If it is so obvious that the concept makes no sense, then why did the FDA put it in their ECA guidance?,
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