Abstract

To evaluate a drug, statistical significance alone is insufficient and clinical significance is also necessary. This paper explains how to analyze clinical data with considering both statistical and clinical significance. The analysis is practiced by combining a confidence interval under null hypothesis with that under non-null hypothesis. The combination conveys one of the four possible results: (i) both significant, (ii) only significant in the former, (iii) only significant in the latter or (iv) neither significant. The four results constitute a quadripartite procedure. Corresponding tests are mentioned for describing Type I error rates and power. The empirical coverage is exhibited by Monte Carlo simulations. In superiority trials, the four results are interpreted as clinical superiority, statistical superiority, non-superiority and indeterminate respectively. The interpretation is opposite in inferiority trials. The combination poses a deflated Type I error rate, a decreased power and an increased sample size. The four results may helpful for a meticulous evaluation of drugs. Of these, non-superiority is another profile of equivalence and so it can also be used to interpret equivalence. This approach may prepare a convenience for interpreting discordant cases. Nevertheless, a larger data set is usually needed. An example is taken from a real trial in naturally acquired influenza.

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