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Steve Cheung's avatar

It seems fair to say this study failed to show that the antibiotic combo was at least 14% better than placebo. The authors truncated their conclusion statement, but this seems to be what they are saying. I’m not sure what the problem is with that.

What this study does not answer is whether the combo may have been 13% better. Or 12 % better. Or some other smaller but still clinically relevant percentage better (however that might be defined or determined).

This is a common issue these days, where estimates of control arm event rates are excessively high, and estimates of effect size are way too large, resulting in underpowered studies. Does that mean potentially useful (but less useful than hoped) therapies are being abandoned? Quite possibly. But I’m not sure what the alternative is. As you say, having much larger studies may be dubious ethically, and prohibitive financially. Perhaps IRBs need to be more active in the design of studies it reviews and approves, to somehow increase likelihood that a real and relevant active arm treatment effect will be found by the study as designed and proposed.

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