引用本文 张新宇，周孟，张清，周天爱，马倩，杨劲*.关于以患者为中心药物开发的见解——现有药物评价体系的重要补充[J].中国食品药品监管.2021.04（207）：44-51. 关于以患者为中心药物开发的见解 ——现有药物评价体系的重要补充 Patient-Focused Drug Development: An Important Supplement to the Existing Drug Evaluation System 张新宇 中国药科大学国际医药商学院 ZHANG Xin-yu School of International Pharmaceutical business, China Pharmaceutical University 周孟 中国药科大学国际医药商学院 ZHOU Meng School of International Pharmaceutical business, China Pharmaceutical University 张清 中国药科大学国际医药商学院 ZHANG Qing School of International Pharmaceutical business, China Pharmaceutical University 周天爱 中国药科大学国际医药商学院 ZHOU Tian-ai School of International Pharmaceutical business, China Pharmaceutical University 马倩 中国药科大学国际医药商学院 MA Qian School of International Pharmaceutical business, China Pharmaceutical University 杨劲＊ 中国药科大学国际医药商学院 YANG Jin* School of International Pharmaceutical business, China Pharmaceutical University 摘 要Abstract 医疗实践不仅需要拥有科学的量化研究, 同时需要具有人文理念的质性研究; 不仅要能够处理数据为主的自然科学问题, 也要能分析主观信息为主的人文科学问题。而在以证据为基础的医学时代，治疗手段的获益- 风险评估格外重视证据的客观性，忽略患者一些主观性的证据，但在临床需求未被满足的情况下，需要患者声音。本文通过分析患者声音的内涵，结合我国临床药物开发现状和FDA 目前的相关实践，以及如何科学收集患者观点，对我国以患者为中心的药物开发提出展望。 Medical practice requires not only scientific quantitative research, but also qualitative research with humanistic concepts; it must be able to not only deal with data-based natural science issues, but also analyze human science issues based on subjective information. In the era of evidence-based medicine, the benefit-risk assessment of medical treatment pays special attention to the objectivity of evidence and ignores subjective evidence coming from patients. But when there are unmet clinical needs, patients’ voices are needed. This article analyzes the connotation of patients’ voice and the current status of clinical drug development in China, introduces practices of the US FDA on patient-focused drug development and methods to scientifically collect patient opinions, and puts forward suggestions for promoting patient-focused drug development in China. 关键词 Key words 药物开发；患者声音；临床价值；获益- 风险评估 drug development; patient voice; clinical value; benefit-risk assessment |
