中药新药临床试验伦理审查应关注的问题

Key Points of Ethic Review on Clinical Trials of Traditional Chinese Medicine

中药临床试验的伦理审查与一般临床试验要求是一致的,都需要审查临床试验的科学性、伦理性,根据中药不同于化学药物并在正式研究前大量的人体应用的特点,中药新药临床试验还需要关注其临床试验前的安全性数据/资料、辨证论治的考虑、合并中药/西药的联合作用、剂量及疗程探索的依据、疗效评价的方法、试验药物的掺和物、对照药物为安慰剂时的依据、药物自命名或改变用药途径等内容。

According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .