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17:49
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Originally posted by Martin37:
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p = 0.05 (usually the minimum standard set by FDA, TGA etc for clinically significant results) meaning there is only a 5% probability that the positive treatment results versus placebo would have occurred by chance. In other words if you ran the trial with same patients and conditions statistically speaking the treatment would show similar positive treatment results versus placebo 95 times out of 100. This is usually the most uncertainty the FDA will accept.or improved ) if the former trial had a low p value. Essentially you are running a similar trial again, so if the original trial p value was 0.01 for instance, then there is an excellent chance similar results will carry into the next trial (i.e. a similar trial run again with the p value of 0.01 should in theory not differ much from having a 99 times out of 100 possibility of achieving the original result from the original trial). If you take nothing away from this apart from a p value <0.05 is good and if you can replicate the first trial as best as possible in the confirmatory phase III trial then there is a very good chance that similar trial results will prevail (and if the original trial p value way say 0.001 then you can bet your bottom dollar that you will achieve similar trial results as the first trial).
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Not quite correct, do not confuse statistical significance and clincial significance. I can reduce pain by 2% in a trial and reach massive statistical signifcance of p=0000001 but who wants to fund or take a Rx that only reduces pain by 2% right. You have to take the effect size with the confidence interval and plot it on a tree plot with effective on the right of the trunk and harmful on the left. Effect size should be all to the right of the trunk with the confidence intervals not touching the trunk. Stat significance just shows that the left CI didnt touch the line of no effect. You have to then compare to the gold standard clinical Rx to judge the clincial significance. In terms of CLBP and CHF secondaries these effects are off the friken charts in terms of clinical significance but only just under 0.01 stat wise
(20min delay)