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药物临床试验安全性报告的规范 被引量：5

A Proposal for Safety Reporting of Drug Randomized Controlled Trials
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摘要 从药物临床试验的定义及各分期对安全性的要求强调安全性报告的重要性。简单介绍药物临床试验安全性报告的现状,并对CONSORT声明扩展版中针对药物有害性临床试验报告的标准及条目进行解释。 To introduce the importance of safety reporting in clinical trials from the aspect of drug clinical trial＇s definition and classification of different stages,briefly summarize the current situation of safety reporting in drug clinical trials,and explain the reporting standards of drug clinical trials based on the recommendations of Consort extension on harm.
作者 邢建民 李迅 刘建平
机构地区 北京中医药大学循证医学中心
出处 《中国药物警戒》 2010年第4期202-205,共4页 Chinese Journal of Pharmacovigilance
基金 国家重点基础研究发展计划(973计划)(No.2006CB504602) 科技部国际合作项目(2009DFA31460)
关键词 安全性 不良事件 临床试验 CONSORT声明 中药 safety adverse event clinical trial Consort statement Chinese Traditional Medicine
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献10

  • 1Cuervo L G,Clarke M.Balancing benefits and harm s in health care[Editorial][J].BMJ,2003,327:65-66.
  • 2Stephanie L Prady,Stewart J Richmond,Veronica M Morton,et al.A Systematic Evaluation of the Impact of Stricta and Consort Recommendations on Quality of Reporting for Acupuncture Trials[J].PLoS ONE,2008,3(2):el577.
  • 3Moher D,Jones A,Lepage L.Use of the Consort statement and quality of reports of randomized trials:a comparative before-andafter evaluation[J].JAMA,2001,285:1992-1995.
  • 4Plint A C,Moher D,Schulz K,et al.Does the Consort checklist improve the quality of retorts of randomized controlled trials A systematic review[J].Fifth International Congress of Peer Review and Biomedical Publication,2005 September 16-18.
  • 5李迅,李昕雪,刘智君,马立新,刘建平.国内期刊中药临床试验安全性报告分析[J].中国药物警戒,2010,7(1):20-24. 被引量：17
  • 6张永贤.临床随机对照试验报告规范[J].华夏医药,2008,3(3):206-206. 被引量：1
  • 7John R A Ioannidis,Stephen J W Evans,Gomzsche P C,et al.Better Reporting of Harms in Randomized Trials:An Extension of the Consort Statement[J].Ann Intern med,2004,141:781-788.
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二级参考文献64

  • 1魏建江.从中药不良反应的客观性探讨建立药物警戒系统[J].中国现代药物应用,2009,3(4):190-191. 被引量：3
  • 2Moher D, Schulz K F, Altman D G. CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. J Am Podiatr Med Assoc, 2001 Sep,91(8):437-442.
  • 3Ioannidis J P, Evans S J , Gotzsehe P C, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement[J]. Ann Intern Med,2004,141(10):781-788.
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  • 7Panagiotis N P, Rachel C, Kristian W, et al.Safety reporting in randomized trials of mental health interventions[J]. Am J Psychiatry, 2004,161:1692-1697.
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共引文献28

同被引文献43

引证文献5

二级引证文献39

中国药物警戒
2010年 第4期

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