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Re: Fosco1 post# 28098

Saturday, 01/25/2020 8:26:04 AM

Saturday, January 25, 2020 8:26:04 AM

Post# of 44552
Everyone, please don’t miss reading Fosco’s closing point from his prior post, it’s dead on:


PS : regarding the early termination posts : no way it can happen whatever the effect size. This is an event driven study, you need to wait for 298 as per the protocol, even if early significance is reached with limited sample size, pharma need to stick to protocol as agreed with FDA. There is no such thing as 3 year measurement of efficacy or survival. It is all about having p<0.05 with sample of 298 events, eg logrank test on survival curves which is measuring the gap between two plots of data, if you stop earlier you are breaking the protocol, reducing the sample size, increasing the standard error which gives an estimate for the efficacy etc

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