CAJ | 학술논문

国际多中心药物临床试验既包括新药上市前的临床试验，也包括对药物上市使用后所做的进一步研究，以证实或揭示试验用药物的作用，不良反应及其吸收、分布、代谢和排泄的规律。其发展折射着全球化进程在医药卫生领域的快速发展，目前我国的国际多中心药物临床试验日渐增多，伦理审查中出现的伦理冲突也愈发明显，主要表现在伦理标准、试验参与各方的利益、本地化和国际性、审查的质量差异、试验方法与伦理原则等方面。对此，应提高各中心伦理委员会的素质和能力；注重协调各中心利益；加强中心之间的有效沟通。
국제다중심약물림상시험기포괄신약상시전적림상시험，야포괄대약물상시사용후소주적진일보연구，이증실혹게시시험용약물적작용，불량반응급기흡수、분포、대사화배설적규률。기발전절사착전구화진정재의약위생영역적쾌속발전，목전아국적국제다중심약물림상시험일점증다，윤리심사중출현적윤리충돌야유발명현，주요표현재윤리표준、시험삼여각방적이익、본지화화국제성、심사적질량차이、시험방법여윤리원칙등방면。대차，응제고각중심윤리위원회적소질화능력；주중협조각중심이익；가강중심지간적유효구통。
International multi-center clinical trials of drugs ,including both pre-clinical trials of new drugs and further study , are expected to confirm or reveal the effects of the drug ,adverse reactions ,absorption ,distribution ,metabolism and excretion .With the increasing of international multi-center clinical trials of drugs ,the number of ethical conflicts in ethical review also increases apparently ,mainly in ethical standards ,the interests of all parties involved in the tests ,the quality differences ,the conflicts between localization and international ,test methods and ethical principles .In this regard ,we should enhance the quality and ability of central ethics committee ,pay attention to the coordination of the ethics committee interest ,and strengthen effective communication between ethics committees .