我国药品临床试验数据清理问题及对策研究
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摘要
目的:分析现阶段我国药物临床试验数据清理存在的问题,在借鉴发达国家经验的基础上,提出我国药物临床试验数据清理的对策和建议。方法:采用文献检索和典型国家经验分析的方法。结果:我国在药品临床试验数据清理法律法规、监督管理以及高素质专业数据清理人才培养等方面亟待发展和完善。结论:应进一步完善药物临床试验数据清理法规;保障EDC系统内的数据安全;CRF设计方案应更加专业化;数据转换实现标准化;加大培养高素质专业化临床试验数据清理人才队伍的力度。
Objective: To analyze the existing problems of drug clinical trial data cleanup in China and to put forward countermeasures and suggestions based on the experience of foreign developed countries. Methods: Literature retrieval and typical national empirical analysis were used. Results: The relevant laws and regulations on drug clinical trial data cleanup need to be perfected, the supervision and management should be enhanced, and the high-quality professional talents of data cleanup need to be cultivated. Conclusion: The regulation of drug clinical trial data cleanup should be further improved to ensure the data security in EDC system. CRF design scheme should be more professional to achieve the standardization of data conversion. Moreover, the cultivation of high-quality professional data cleanup talents should be strengthened.
Objective: To analyze the existing problems of drug clinical trial data cleanup in China and to put forward countermeasures and suggestions based on the experience of foreign developed countries. Methods: Literature retrieval and typical national empirical analysis were used. Results: The relevant laws and regulations on drug clinical trial data cleanup need to be perfected, the supervision and management should be enhanced, and the high-quality professional talents of data cleanup need to be cultivated. Conclusion: The regulation of drug clinical trial data cleanup should be further improved to ensure the data security in EDC system. CRF design scheme should be more professional to achieve the standardization of data conversion. Moreover, the cultivation of high-quality professional data cleanup talents should be strengthened.
引文
[1]旅医网.国内新药试验数据造假严重,你吃的药可能就这样上市的[EB/OL].(2016-12-06)[2017-04-15].http://www.sohu.com/a/110909951_400591.
[2]谢高强,姚晨.数据管理在临床研究中的地位和作用[J].北京大学学报(医学版),2010,(6):641-643.
[3]陈昕.利用SAS优化不良事件数据的人工检查流程[D].上海:复旦大学,2013.
[4]国家食品药品监督管理总局.国家食品药品监督管理总局令第3号药物临床试验质量管理规范[S].2016.
[5]SCDM.Good Clinical Data Management Practices 2013[EB/OL].[2017-03-01].http://scdm.org/publications/gcdmp/.
[6]王雅倩,杨悦.CDISC标准与临床试验数据标准化[J].中国医药指南,2016,(12):296-297.
[7]邓亚中,于嘉,刘川,等.电子化时代临床数据管理现状和未来趋势[J].中国新药杂志,2014,(8):879-884.
[8]EMEA.Extrapolation of results from clinical studies conducted outside Europe to the EU-population[EB/OL].[2017-03-15].http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001237.jsp&mid=.
[9]曹红波,刘智,李楠,等.药品上市后临床试验远程数据管理模式的架构[J].天津中医药,2014,(12):730-734.
[2]谢高强,姚晨.数据管理在临床研究中的地位和作用[J].北京大学学报(医学版),2010,(6):641-643.
[3]陈昕.利用SAS优化不良事件数据的人工检查流程[D].上海:复旦大学,2013.
[4]国家食品药品监督管理总局.国家食品药品监督管理总局令第3号药物临床试验质量管理规范[S].2016.
[5]SCDM.Good Clinical Data Management Practices 2013[EB/OL].[2017-03-01].http://scdm.org/publications/gcdmp/.
[6]王雅倩,杨悦.CDISC标准与临床试验数据标准化[J].中国医药指南,2016,(12):296-297.
[7]邓亚中,于嘉,刘川,等.电子化时代临床数据管理现状和未来趋势[J].中国新药杂志,2014,(8):879-884.
[8]EMEA.Extrapolation of results from clinical studies conducted outside Europe to the EU-population[EB/OL].[2017-03-15].http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001237.jsp&mid=.
[9]曹红波,刘智,李楠,等.药品上市后临床试验远程数据管理模式的架构[J].天津中医药,2014,(12):730-734.
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