clinical significance

EVIDENCE-BASED MEDICINE

The degree to which a clinical finding warrants attention and whether an intervention is of practical relevance.

Some findings–e.g., the results of a blood test, are statistically, but not clinically, significant. In a trial with a large number of patients, a small difference between treatment and control groups may be statistically significant, but not clinically significant. In a trial with few patients, an important clinical difference may be observed that does not achieve statistical significance, and a larger trial would be needed to determine if it was a statistically significant difference. 

The criterion or criteria for clinical significance should be stated in the protocol. The phrase clinical significance shouldn’t be used unless it is operationally defined. 

References http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=700052&sk=&date=1&pageID=7