| 药物临床试验中研究人员职业精神问题分析与对策 |
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| 引用本文： | 白彩珍,赵志刚,崔向丽,黄佳.药物临床试验中研究人员职业精神问题分析与对策[J].中国新药杂志,2010(8). |
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| 作者姓名： | 白彩珍 赵志刚 崔向丽 黄佳 |
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| 作者单位： | 首都医科大学附属北京天坛医院药剂科; |
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| 摘 要： | 《医师宣言》和药物临床试验质量管理规范(GCP)均要求医疗服务将患者/受试者的利益放在首位。在临床试验的科学性、社会性与受试者权益的冲突中,研究人员往往忽略受试者的权益而选择前者。文中通过对临床试验中一些问题的分析,认为不但要强调研究人员的职业精神的教育,重视职业精神的监督,也要重视创造一种能够使受试者安全、研究人员受益的共赢的文化环境。
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| 关 键 词： | 药物临床试验 研究人员 职业精神 受试者权益 |
Problems in researcher's professionalism in clinical trials and its solutions |
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| BAI Cai-zhen,ZHAO Zhi-gang,CUI Xiang-li,HUANG jia.Problems in researcher's professionalism in clinical trials and its solutions[J].Chinese Journal of New Drugs,2010(8). |
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| Authors: | BAI Cai-zhen ZHAO Zhi-gang CUI Xiang-li HUANG jia |
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| Institution: | BAI Cai-zhen,ZHAO Zhi-gang,CUI Xiang-li,HUANG jia(Department of Pharmacy,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100050,China) |
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| Abstract: | According to both of the Physicians' Charter and the Good Clinical Practice,the subject's rights and benefits should be considered first.In practices,between the conflicts of scientific and social benefits and subject's rights and benefits,researchers sometimes neglect the latter one.After analyzed problems in clinical trials,it is realized that not only monitoring researchers' behaviors should be emphasized in terms of professional ethics,but also attention to developing a win-win culture environment for s... |
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| Keywords: | clinical trial researchers professionalism subject\'s rights and benefits |
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