以患者为中心的临床试验:医药研发新模式

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

  • 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。

     

    Abstract: With the acceleration of innovative drugs launched in the market, clinical trials have become increasingly complex and costly. Integration of patients' perspective and engagement into the clinical research process is essential to the success of the trials, which leads to the emergence of the concept of patient-centric clinical trials. Compared to the conventional paradigm of clinical trials, patient-centric clinical trials have the potential to increase the feasibility of study protocol, to speed recruitment and execution, and to promote the success of trials. It calls for the institutions and investigators of clinical trials to be aware of and adapt to patient-centric initiatives. In this article, we highlight technologies and actions that can be used to enhance patients' engagement in the entire process of drug development, covering protocol development, trial conduction, and result publication.

     

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