Ann: Imugene HER-Vaxx Phase 2 PFS Data and Flags Three New Trials, page-210

https://www.ahajournals.org/doi/10.1161/STROKEAHA.114.006138

good details on P value.

Suppose in a large (n=2100 per group) clinical trial of acute stroke to detect a difference of 5% in good outcome between 2 treatment groups, the typical Table 1 shows the mean baseline systolic blood pressure of 125 and 120 mm Hg, each with standard deviation of 15 mm Hg. The difference is 5 mm Hg, and the t test yields P<0.01. But one could hardly argue that this difference is clinically significant. In contrast, suppose a small study (say, n=40 in each group) to test intensive serum glucose control in acute stroke patients had enrolled subjects with history of diabetes mellitus: 20% in one group and 33% in the other. The χ2 test yields P=0.20, not a statistically significant difference at the α of 0.05. Nevertheless, a 13% difference in the proportion of subjects with history of diabetes mellitus is likely to be a clinically important factor to consider in the analysis and interpretation of the primary outcome. In other words, P values are meaningless at best, and potentially misleading, to ascertain whether the treatment groups are balanced in the baseline characteristics. The same issue of seeking statistical significance without consideration for clinical relevance also applies to analyses of outcomes data. Many articles have been published in both statistical and clinical journals addressing this topic and will not be addressed further here.4,5