在新型冠狀病毒疫情爆發(fā)之際，應(yīng)運(yùn)而生的"新藥"臨床試驗(yàn)是一特點(diǎn)；為滿足用藥需求，對(duì)某些患者采用"同情用藥"也是一可能的途經(jīng)。介紹美國(guó)、歐盟和世界衛(wèi)生組織的"同情用藥"發(fā)展歷程和原則?；仡櫸覈?guó)的"同情用藥"的發(fā)展變遷和我國(guó)食品藥品監(jiān)督管理局的"同情用藥"原則。疫情爆發(fā)以來的治療藥物需求在增長(zhǎng)，也給商家?guī)戆l(fā)展的機(jī)遇和挑戰(zhàn)，帶來了臨床研究的"熱潮"，因此，必須維護(hù)新藥和新適應(yīng)癥臨床試驗(yàn)的科學(xué)性是一新課題。在復(fù)雜情況下，嚴(yán)謹(jǐn)科學(xué)的衛(wèi)生統(tǒng)計(jì)學(xué)與流行病學(xué)有關(guān)的研究，在國(guó)家新藥臨床研究規(guī)范（GCP）大原則下，需要牢固樹立科學(xué)、規(guī)范、有序地開展新型冠狀病毒肺炎治療藥物臨床試驗(yàn)的原則，才能做到戰(zhàn)勝"疫情"與"創(chuàng)新"兩不誤。在疫情急救醫(yī)療的非常時(shí)期，開展以循證醫(yī)學(xué)研究新藥試驗(yàn)項(xiàng)目需要?jiǎng)?chuàng)新、需要科學(xué)、需要嚴(yán)謹(jǐn)。只有"戒除浮躁，守正創(chuàng)新"，我國(guó)新藥臨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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