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exwannabe

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exwannabe

Re: dennisdave post# 596752

Monday, 05/29/2023 11:24:43 AM

Monday, May 29, 2023 11:24:43 AM

Post# of 704734

The FDA has never said that, thats a blunt falsehood. Its not for nothing that you never quote FDA regulations with a link. Why is that?


I have quoted the FDA guidance plenty of times. Once more:

Overall survival should be evaluated in randomized controlled studies. Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival.



You can also see on page 5 the table of recommended oncology endpoints shows OS in a randomized trial only.
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