Shi Y K, Sun Y
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Zhonghua Zhong Liu Za Zhi. 2021 Jun 23;43(6):696-706. doi: 10.3760/cma.j.cn112152-20210218-00139.
Medical oncology is a subject characterized by drug therapy. Continuous research and development (R&D) of high-efficiency and low-toxic anti-cancer drugs is the premise of the development of medical oncology. Clinical trials play an indispensable role in the process from drug R&D to application, which determines the success or failure of a new drug. The clinical trials for anti-cancer investigational new drug (IND) in China began in 1960, and have developed rapidly since 2008. With the guidance and support of national policies, as well as involved by all aspects of the society, the R&D of anti-cancer drugs in China has changed from imitation to innovation. China innovative anti-cancer drugs have been widely recognized in the world, and more and more new domestic anti-cancer drugs have been used in clinical practice, bringing benefit to Chinese cancer patients. This article reviews the development of the clinical trials for anti-cancer IND in China from 1960 to 2020, and the main achievements having been made in the past 60 years. A thorough understanding of this history will help us keep in mind the mission and grasp the direction, as to make more achievements when implementing the strategy of "Healthy China" .
肿瘤内科是以药物治疗为特色的学科。高效低毒抗癌药物的不断研发是肿瘤内科发展的前提。临床试验在药物研发到应用的过程中发挥着不可或缺的作用，它决定着一种新药的成败。我国抗癌 investigational new drug（IND，研究性新药）临床试验始于1960年，2008年以来发展迅速。在国家政策的引导和支持以及社会各界的参与下，我国抗癌药物研发已从仿制走向创新。我国创新抗癌药物在国际上得到广泛认可，越来越多国产新型抗癌药物应用于临床实践，造福中国癌症患者。本文回顾了1960年至2020年我国抗癌IND临床试验的发展历程以及过去60年所取得的主要成就。深入了解这段历史将有助于我们牢记使命、把握方向，在实施“健康中国”战略中取得更多成绩。
