Many people may find statistical analysis to be one of the major hurdles in planning a clinical study. But did you know that there is something that statistical experts consider more important than the validity of analytical methods and P-values? This is considered to be worth addressing, even without expertise in medical statistics.

In this special issue, we will discuss  with an expert on how clinicians who want to start clinical research should think concerning this issue. Mr. Hiroki Yoshida (Representative Director, Data Seed Corporation), a medical statistics consultant who has managed a medical statistics blog, published books, and contributed to the New England Journal of Medicine as a statistical analyst, explained how to approach this topic.