As we know a lot of debate is going on regarding the current p-value threshold for the declaration of statistical significance (P < 0.05); even some peer-reviewed journals stopped publishing papers with p-values. Recently, a  more stringent p-value threshold for a statistical significance (P < 0.005) is proposed by a number of leading statisticians for the declaration of statistical significance for a new discovery (I think the paper will be published in the forthcoming Nature Human Behavior and the prepublication version can be accessed from this link https://scholar.harvard.edu/files/dtingley/files/sig-naturehumanbehaviour.pdf). This seems one step forward to address the issue with p-value (especially regarding the reproducibility of findings), but how this proposal will be adapted in clinical trials design particularly in dealing the trade-off between type I and type II errors is debateable. For example, to maintain the lower quite well-accepted 80% power, the sample size needs to be increased by about 70% using the new type I error (alpha=0.005) or compromise the power which will be less than 50% in order to keep the same sample size as the one from the standard approach (i.e. alpha=0.05) for a two-sided test. I think the issue with p-value threshold for a statistical significance is not going to stop here and this paper is going to spark a lot of new debate as long as the balance between budget (resource) and statistical power (the probability of finding an effect if it is there) is the main factor in clinical trials design.

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