在新型冠状病毒疫情爆发之际，应运而生的"新药"临床试验是一特点；为满足用药需求，对某些患者采用"同情用药"也是一可能的途经。介绍美国、欧盟和世界卫生组织的"同情用药"发展历程和原则。回顾我国的"同情用药"的发展变迁和我国食品药品监督管理局的"同情用药"原则。疫情爆发以来的治疗药物需求在增长，也给商家带来发展的机遇和挑战，带来了临床研究的"热潮"，因此，必须维护新药和新适应症临床试验的科学性是一新课题。在复杂情况下，严谨科学的卫生统计学与流行病学有关的研究，在国家新药临床研究规范（GCP）大原则下，需要牢固树立科学、规范、有序地开展新型冠状病毒肺炎治疗药物临床试验的原则，才能做到战胜"疫情"与"创新"两不误。在疫情急救医疗的非常时期，开展以循证医学研究新药试验项目需要创新、需要科学、需要严谨。只有"戒除浮躁，守正创新"，我国新药临床研究走向世界才有希望。

During the outbreak of new coronavirus, clinical trials of "new drugs" are characteristic in clinical studies. The use of "compassion use" for some patients is also a possible route to meet the need for therapy. This paper introduces the development process and principles of "compassionate use" in the United States, the European Union, and the world health organization. This paper reviews the development and change of "compassionate use" in China and the principle of "compassionate use" in China's medicinal product administration. Since the outbreak of the epidemic, the demand for therapeutic drugs is growing, and it also brings opportunities and challenges to the development of the business, and brings the "upsurge" of clinical research. Therefore, it is necessary to maintain the scientific nature of clinical trials of new drugs and new indications. In complex situations, rigorous and scientific research on health statistics and epidemiology, it is necessary to firmly establish the principle of scientific, standardized, and orderly clinical trials of new drugs for the therapeutic coronavirus pneumonia diseases, so as to overcome the "epidemic" and "innovation" under the national GCP principle. In the emergency medical treatment of epidemic diseases, the new drug test project based on evidence-based medicine needs innovation, science, and preciseness. Only by "giving up impetuosity and keeping to right innovation", the clinical research of new drugs in China can reach the world.

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