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Just want to put this out there for more discerning readers not easily swayed by @Bioconlimited hype on #Itolizumab.. two huge issues with their pivotal trial. First a very small sample size of 21 Rx arm and 10 control arm is underpowered to detect any significant effect size.1/3
A 'power' calculation is a basic step prior to any study to make sure you enrol enough subjects to actually statistically prove that a drug is effective. For showing a 50% benefit for example, assuming a 30% mortality, and a power of 80% you wld need a sample size of 100. 2/4
2nd, thanks to this their reported outcomes are going to have wide confidence intervals for their effect estimates. Here is my calculation for their press release reported mortality benefit (no deaths in 21 rxed Vs 3 deaths in 10 control). Gr8 RR (93% reduction in death) but 3/4
look at the confidence intervals 0.004 to 1.26, it basically means that the true RR might range from 99% fewer deaths (too awesome) to the other side of the coin 26% more deaths. NOT conclusive. This is why a bigger trial is imperative! 4/4
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