My understanding is that a 20% or higher efficacy with a P value of .001 and CI of 99% would mean the trial is halted for efficacy because the data was very robust ...ie very low risk that the results are due to chance . However I'll defer to JL and his Harvard background in stats as well as HDGabor with his stats background ...for the final word.
JELIS IMHO is a guide only . Many differences in the populations studied . Just because JELIS showed benefit does not mean to me that RI will be halted at interim. I think the chances are good but by no means certain. Understand also that JELIS was an open labelled trial ...no matter where you stand on open label vs double blinded ...fact is most consider the data from open labelled trials less robust
The success of RI IMHO is compromised by 1) what I saw as JZ's initial drive to recruit as fast as possible to get the numbers up to be able to submit for the Anchor indication....so a lot with moderate risk vs high risk were enrolled. 2)Not requiring low HDL as a primary qualification for enrollment.
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