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以患者为中心的临床试验:医药研发新模式

谢静 王焕玲

谢静, 王焕玲. 以患者为中心的临床试验:医药研发新模式[J]. 协和医学杂志, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056
引用本文: 谢静, 王焕玲. 以患者为中心的临床试验:医药研发新模式[J]. 协和医学杂志, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056
XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056
Citation: XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056

以患者为中心的临床试验:医药研发新模式

doi: 10.12290/xhyxzz.2021-0056
基金项目: 

北京市医学伦理管理和审查质量提高项目 202002-4

详细信息
    通讯作者:

    王焕玲  电话:010-69158360,E-mail:wanghuanling@pumch.cn

  • 中图分类号: R-969.4; R-3; R4

Patient-centric Clinical Trials: A New Paradigm for Drug Development

More Information
  • 摘要: 随着创新药物研发速度加快,临床试验复杂性越来越高,把患者意见和参与整合进临床试验全流程成为项目成功的必要条件,此种医药研发新模式被称为“以患者为中心的临床试验”。与传统临床试验相比,以患者为中心的临床试验可有效提升方案可行性、加速研究实施进程、提高成功率,其价值获得了产业界和监管部门的共识,临床试验机构和研究者应重视和主动适应临床试验模式的改变。本文介绍以患者为中心的临床试验的概念,分析该模式出现的背景,梳理现阶段以患者为中心的临床试验的实现方式,并分析其面临的挑战,旨在提高临床试验机构和研究者的认识。
    作者贡献:谢静负责资料收集及文章撰写;王焕玲负责文章审校。
    利益冲突:
  • 图  1  临床试验不同阶段实现以患者为中心的方式

    PK: 药代动力学;PD: 药效动力学

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出版历程
  • 收稿日期:  2021-01-18
  • 录用日期:  2021-04-22
  • 网络出版日期:  2021-09-15
  • 刊出日期:  2021-11-30

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