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中国临床药理学与治疗学 ›› 2014, Vol. 19 ›› Issue (3): 320-322.

• 药物临床试验会议专栏 • 上一篇    下一篇

浅谈I期临床试验受试者管理体会

黄萍1, 左荣1, 夏春华2, 熊玉卿2   

  1. 1南昌大学第一附属医院国家药物临床试验机构,南昌 330006,江西;
    2南昌大学临床药理研究所,南昌 330006,江西
  • 收稿日期:2014-02-25 修回日期:2014-03-10 出版日期:2014-03-26 发布日期:2014-04-10
  • 作者简介:黄萍,女,硕士,副主任医师,从事新药I期临床试验管理工作。Tel: 0791-88699340 E-mail: hp0929@yeah.net
  • 基金资助:
    国家十二五“重大新药创制”科技重大专项——构建国际标准的规范化药物临床试验研究与评价技术平台(消化系统疾病)(2011ZX09302-007-03)

Brief introduction to phase I clinical trial subjects management

HUANG Ping1, ZUO Rong1, XIA Chun-hua2, XIONG Yu-qing2   

  1. 1State Drug Clinical Trial Agency,the First Affiliated Hospital of Nanchang University,Nanchang 330006,Jiangxi,China;
    2Institute of Clinical Pharmacology,Nanchang University,Nanchang 330006,Jiangxi,China
  • Received:2014-02-25 Revised:2014-03-10 Online:2014-03-26 Published:2014-04-10

摘要: 探讨I期临床试验过程中受试者招募和受试者依从性的管理。分析招募的难点和提高招募效率的措施。在试验全过程中,研究人员扎实的医学知识技能和诚挚的关心、尊重、友善是提高受试者依从性的关键所在。

关键词: I 期临床试验, 受试者, 招募, 依从性

Abstract: Discuss subject recruitment and compliance management in the process of the phase I clinical trial. Analysis the difficulties in recruiting subjects and take effective measures to improve recruitment efficiency and subject compliance. In the whole process of trial, improving subject compliance depends mainly on researchers' sincere care, respect, kindness and solid knowledge of medical skill.

Key words: phase I clinical trial, subject, recruitment, compliance

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