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Re: GD post# 32896

Monday, 08/17/2020 7:51:40 AM

Monday, August 17, 2020 7:51:40 AM

Post# of 43784
GD: regarding Vical's IDMC meetings recommendations, I do not know the specifics but

Usually IDMC meet at 50%, 75% of # of events, interim endpoints
This might be not enough to stop for futility, 25% being still far away from the full power of the study. It might be enough for efficacy if p<0.05 (meaning large effect size).
HR (which is a mean measure) might not be very meaningful, if the confindence interval includes the "1" value : was the Confidence Interval provided in the study you mentionned ?

In the case of Cel SCI , we are talking about a meeting held in April 2020, may be 1% away from final event. The october'19 meeting, likely 4% away from endpoint. This is very close from the trial design power, so I would say that if IDMC run a conditional power analysis, they have either seen futility or efficacy as a 99% outcome when trial finishes, or were still in the grey undecidable zone (around 10% benefit, but may-be with a 5% probability).
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