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p3analyze

09/07/07 8:27 AM

#4800 RE: rancherho #4799

"A close call on the efficacy question would be unlikely to give rise to early termination, but clearly poor or outstanding results may."

Agreed - either poor or good efficacy results would have to cross preset boundaries for alpha (superiority) and beta (futility) error. Termination due to safety signal - however is rare. Mainly because of practical issues (including higher tolerance of added toxicity with onco drugs and time lag with data reporting), safety monitoring in oncology trials is more of a formality, and rarely leads to early termination until very late in the game.