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临床试验所提供的医学数据和结果,是评价和证明试验药物有效性和安全性的重要证据。进行临床试验可以督促生产企业不断改善药物质量、改进疗效,有效避免不良反应事件的发生,因而有人主张应该要求中药新药在投入市场前进行临床试验。然而,具体到中药,因其自身的特点以及临床评价标准的严重缺陷,使部分品种的有效性及安全性难以评价,并因此影响其上市,在人力、物力、财力、时间等方面造成巨大的浪费。因此也有部分人士认为不应该要求中药新药研发进行临床试验。本期辩论会围绕“该不该要求中药新药研发进行临床试验”这个辩题,邀请持不同观点的中药学、西药学专家,药物生产企业经理以及部分医疗机构临床医生展开了激烈的辩论。
The medical data and results provided in clinical trials are important evidence to evaluate and demonstrate the efficacy and safety of the test drugs. To carry out clinical trials can urge manufacturers to continuously improve drug quality, improve curative effect and effectively avoid adverse reaction events. Therefore, some people advocate that traditional Chinese medicine should be required to be put into clinical trial before entering the market. However, specific to traditional Chinese medicine, because of its own characteristics and serious defects in clinical evaluation criteria, so that the effectiveness and safety of some species is difficult to evaluate, and thus affect the listing, in terms of manpower, material and financial resources, time caused huge waste. Therefore, some people think that should not require the development of traditional Chinese medicine for clinical trials of new drugs. This debate will focus on the “should not require the development of traditional Chinese medicine research and development of new clinical trials,” the debate, inviting different views of traditional Chinese medicine, Western medicine experts, drug manufacturers managers and some medical institutions clinicians heated debate .