2018 Volume 38 Issue 2 Pages 153-161
Many clinical studies are conducted in Japan with sample sizes that are not deter-mined statistically. Application of Neyman-Pearson type statistical tests to data from such studies is not justifiable and should be stopped. Also 5% significance level that is commonly employed in a clinical study without taking into account disease, drug and other factors is not justifiable. Alternatively, the use of p-value is recommended in this paper as a measure of showing the magnitude of difference of two treatments; it is the role of principal investigator to summarize the study results by considering disease, drug and other factors, sample sizes and p-value.