| 药物临床试验伦理委员会的建设与展望 |
| |
| 引用本文： | 王晨,白彩珍,姚铁男,赵志刚.药物临床试验伦理委员会的建设与展望[J].药品评价,2011,8(4):4-8. |
| |
| 作者姓名： | 王晨 白彩珍 姚铁男 赵志刚 |
| |
| 作者单位： | 1. 首都医科大学附属北京天坛医院院长办公室,北京,100050
2. 首都医科大学附属北京天坛医院药剂科,北京,100050 |
| |
| 摘 要： | 目的:推动中国药物临床试验伦理委员会的建设和发展.方法:回顾性分析药物临床试验伦理委员会在管理与审查中存在的问题,并提出相应的解决方法.结果和结论:随着卫生主管部门、机构、研究者以及申办者等对伦理审查工作的重视,药物临床试验伦理委员会的建设将会取得快速发展.
|
| 关 键 词： | 药物临床试验 伦理委员会 管理 伦理审查 展望 |
Development and Prospects of Independent Ethical Committee for Drug Clinical Trial |
| |
| WANG Chen,BAI Cai-zhen,YAO Tie-nan,ZHAO Zhi-gang.Development and Prospects of Independent Ethical Committee for Drug Clinical Trial[J].Drug Evaluation,2011,8(4):4-8. |
| |
| Authors: | WANG Chen BAI Cai-zhen YAO Tie-nan ZHAO Zhi-gang |
| |
| Institution: | 1. Dean＇s Office, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing 100050; 2. Department of Pharmacy, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing 100050) |
| |
| Abstract: | Objective： To promote the development of Institutional Review Board （1RB） for drug clinical trial. Methods： Retrospectively analyse the common problems in the management and the practice of IRB, and give some solutions to the problems. Results and Conclusion＂ With more and more attention be paid to the IRB management by the Government, Institution, Investigators, as well as the sponsor and other stakeholders, the greater progress of the IRB for drug clinical trial in China will be achieved in the near future. |
| |
| Keywords: | Drug clinical trial Institutional Review Board （IRB） Management Ethical reviewing Prospects |
| 本文献已被 维普 万方数据 等数据库收录！ |
|
