Characteristic of TCM and the impact on ethics review of clinical research involving Chinese Medicine

摘要

Good ethics review of research protocol should achieve the effect of protecting human subjects, and make the protocol to objectively evaluate the effect and safety of the new drug. Traditional Chinese Medicine (TCM) is different from Western Medicine (WM) in terms of both the theoretical concept and the concrete practice, three main features of TCM is prominent in the context of clinical research when compared to WM, Multi-component mixtures, Substantial human using experience before clinical research, Syndrome oriented treatment, these three features all have impact on ethics and scientific review of research protocols, in concrete, the safety consideration, non-clinical research requirement, quality requirement of the drug, enrollment, efficacy evaluation, etc, additional consideration should be applied to achieve through review to objectively reflect the characteristics of the TCM new drug besides complying with common scientific principles.