Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote
pharmaphorum
OCTOBER 30, 2022
The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.
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