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目的以欧洲药品管理局(European Medicine Agency,EMA)的药物临床试验数据公开制度为借鉴,为我国药物临床试验数据公开制度的构建和完善提供建议。方法以文献分析为主,结合案例分析,在对EMA的药物临床试验数据公开的发展历程进行总结的基础上,从公开途径、公开内容、公开程序和争议处理机制四方面详细分析EMA的药物临床试验数据公开制度。结果双向互补的公开途径、全面具体的公开内容、明确规范的公开程序、利益兼顾的争议处理机制是EMA的药物临床试验数据公开制度的显著特点。结论我国可以参考EMA的成功经验,运用法律和技术手段,明晰公开途径、逐步扩展公开内容、完善公开程序以及建立相应的争议处理机制,进而发展我国的药物临床试验数据公开制度。
Objective To make use of the open system of drug clinical trial data of the European Medicine Agency (EMA), to provide suggestions for the construction and perfection of the open system of drug clinical trial data in China. Methods Based on the literature analysis, combined with case analysis, based on the summary of the public development of drug clinical trial data in EMA, the author analyzed the clinical results of EMA in detail from four aspects: open channels, open contents, open procedures and dispute resolution mechanisms Test data disclosure system. Results Two-way complementation of open channels, comprehensive and specific disclosure, a clear and standardized open procedures, the interests of both the dispute resolution mechanism is a prominent feature of EMA drug clinical trial data disclosure system. Conclusions Our country can make reference to the successful experience of EMA, make use of the legal and technical means, clarify the open way, gradually expand the public content, improve the public procedure and establish the corresponding dispute handling mechanism, and then develop the open system of clinical trial data in our country.