| 我国药物Ⅰ期临床试验受试者招募及管理存在的问题 |
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| 引用本文： | 张正付,沈玉红,李正奇.我国药物Ⅰ期临床试验受试者招募及管理存在的问题[J].中国临床药理学与治疗学,2012,17(5):481-484. |
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| 作者姓名： | 张正付 沈玉红 李正奇 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心,北京,100061 |
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| 摘 要： | 受试者招募是影响Ⅰ期临床试验质量的一个重要环节。本文针对我国Ⅰ期临床试验受试者招募与管理存在的问题,探讨相应的对策,以期保护受试者的权益和安全,提高我国药物I期临床试验的水平和质量。
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| 关 键 词： | 招募 受试者 Ⅰ期临床试验 |
Problems in the recruitment and management of trial subjects for phase Ⅰ clinical trials in China |
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| ZHANG Zheng-fu
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SHEN Yu-hong
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LI Zheng-qi.Problems in the recruitment and management of trial subjects for phase Ⅰ clinical trials in China[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2012,17(5):481-484. |
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| Authors: | ZHANG Zheng-fu SHEN Yu-hong LI Zheng-qi |
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| Institution: | Center for Drug Certification,State Food and Drug Administration,Beijing 100061,China |
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| Abstract: | Recruitment of trial subjects is an important part to affect the quality for phase Ⅰ clinical trial.This paper reviews many problems in the recruitment and management of trial subjects for phase Ⅰ clinical trial at present,and explores appropriate measures in order to protect the rights,benefits and safety of trial subjects,improve the level and quality of phase I clinical trials in China. |
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| Keywords: | Recruitment Trial subjects Phase Ⅰ clinical trial |
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