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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.
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.
XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital.
Citation: XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital.

以患者为中心的临床试验:医药研发新模式

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

Funds: 

Beijing Municipal Program of Quality Improve in Practice of Medical Ethics and Ethical Review (grant number 202002-4)

  • 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。
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出版历程
  • 收稿日期:  2021-01-18
  • 网络出版日期:  2021-09-17

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