ABSTRACT
In clinical trials, a typical approach for evaluation of safety and efficacy of a test treatment under investigation is to first test for the null hypothesis of “no treatment difference in efficacy,” based on clinical data collected under a valid trial design. If significant difference is observed, the investigator would reject the null hypothesis of no treatment difference and then conclude the alternative hypothesis that there is a difference in favor of the test treatment. If there is a sufficient power for correctly detecting a clinically meaningful difference (improvement) when such a difference truly exists, we claim that the test treatment is efficacious. The test treatment will then be reviewed and approved by a regulatory agency such as the FDA if the test treatment is well tolerated and there appears to be no safety concerns. We will refer to medicine developed based on this typical approach as traditional medicine.
