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大量研究结果表明,大多数后期新药研发的失败是由于疗效不确定。究其原因,往往是因为对药物靶点和疾病生物学之间的关系缺乏了解。然而,这也是运用传统研发模式的必然结果。由于基础和临床的脱节,早期临床和后期临床的脱节,传统的研发模式根本不能适应靶向药物的研发需求。本文通过对生物标记物、0期临床试验和适应性临床试验的讨论和举例来探讨转化医学在新药研发中的应用。同时,本文也有选择地列举了国内外近年来转化医学的一些成就和国内转化医学的新趋势,进一步讨论转化医学在新药研发中的潜力。毫无疑问的是,随着分子基因检测,数字影像和标记技术的不断成熟,转化医学在新药研发中的作用将会更加突出。
Numerous studies show that the failure of most of the new drug development is due to the uncertainty of efficacy. The reason is often due to lack of understanding of the relationship between drug targets and disease biology. However, this is also the inevitable result of using the traditional R & D mode. Because of the disconnection between the basic and the clinical, the early clinical and the late clinical out of touch, the traditional research and development model simply can not meet the research and development needs of targeted drugs. This article discusses the use of translational medicine in the development of new drugs through discussions and examples of biomarkers, Phase 0 clinical trials and adaptive clinical trials. At the same time, this article also selectively lists some achievements of translational medicine at home and abroad in recent years and new trend of domestic translational medicine, and further discusses the potential of translational medicine in the research and development of new drugs. Undoubtedly, as molecular genetic testing, digital imaging and labeling technologies continue to mature, translational medicine will play a more prominent role in the research and development of new drugs.