国际多中心药物试验伦理审查中的冲突与防控策略

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。

The Conflicts and Prevention Strategies in the Ethical Review of International Multi-center Trials of Drugs

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.