| 我国医疗器械临床试验现状与思考 |
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| 引用本文： | 肖忠革,周礼明,田卓平,金剑,诸慧.我国医疗器械临床试验现状与思考[J].中国医疗器械杂志,2009,33(5):369-371. |
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| 作者姓名： | 肖忠革 周礼明 田卓平 金剑 诸慧 |
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| 作者单位： | 上海交通大学医学院附属第九人民医院,上海市,200011 |
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| 摘 要： | 目的：提高我国医疗器械临床试验的质量和水平。方法：分析我国医疗器械临床试验现状及存在问题．探讨解决办法。结果与结论：我国医疗器械临床试验现状表现为起点低、法规制度不完整，申办者和研究者不够重视，临床试验质量不高，需要在涉及医疗器械临床试验的各方面加以完善。
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| 关 键 词： | 医疗器械 临床试验 伦理委员会 植入 管理 |
Current Situation and Consideration of Medical Instrument Clinical Trial in China |
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| XIAO Zhong-ge,ZHOU Li-ming,TIAN Zhou-ping,JIN Jian,ZHU Hui.Current Situation and Consideration of Medical Instrument Clinical Trial in China[J].Chinese Journal of Medical Instrumentation,2009,33(5):369-371. |
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| Authors: | XIAO Zhong-ge ZHOU Li-ming TIAN Zhou-ping JIN Jian ZHU Hui |
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| Affiliation: | (Shanghai Ninth People＇ s Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, 200011) |
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| Abstract: | OBJECTIVE To improve the quality of medical instrument clinical trial in China. METHODS A systematic analysis on current situation of medical instrument clinical trial in China is conducted to find a way out of problems. RESULTS ＆ CONCLUSIONS There is a low level of medical instrument clinical trial now in China. There are still many shortcomings in law and regulations of medical instrument clinical trial. The sponsors and s do not know medical instrument clinical trial well, the measures of quality related to medical instrument clinical trial must be improved. |
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| Keywords: | medical instrument clinical trial |
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