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中国临床药理学与治疗学 ›› 2012, Vol. 17 ›› Issue (5): 481-484.

• 专论 •    下一篇

我国药物I期临床试验受试者招募及管理存在的问题

张正付, 沈玉红, 李正奇   

  1. 国家食品药品监督管理局药品认证管理中心,北京 100061
  • 收稿日期:2011-11-30 修回日期:2012-03-20 出版日期:2012-05-26 发布日期:2012-05-28
  • 通讯作者: 李正奇,男,主任药师,研究方向:药物临床试验监管。E-mail: sfdaccd@163.com
  • 作者简介:张正付,男,博士,研究方向:药物临床试验监管。E-mail::zzfbj@sina.com

Problems in the recruitment and management of trial subjects for phase I clinical trials in China

ZHANG Zheng-fu, SHEN Yu-hong, LI Zheng-qi   

  1. Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China
  • Received:2011-11-30 Revised:2012-03-20 Online:2012-05-26 Published:2012-05-28

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。

关键词: 招募, 受试者, I期临床试验

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.

Key words: Recruitment, Trial subjects, Phase I clinical trial

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