Timelines of translational science: From technology initiation to FDA approval.
Timelines of translational science: From technology initiation to FDA approval.
复制标题
DOI：
10.1371/journal.pone.0177371
复制
发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Ledley FD
中科院分区：
文献类型：
--
作者：
McNamee LM;Walsh MJ;Ledley FD
虽然临床开发的时间表已经被广泛研究，但关于从启动新药靶点研究到批准基于这项研究的药物的更广泛途径的数据很少。我们使用技术成熟的分析模型检查了2010-2014年间FDA批准的138种药物和生物制品的翻译科学时间表。对102个产品目标的研究显示出一个特征(S曲线)成熟模式，在统计定义的技术初始点和确定型点之间呈指数增长。启动试验的中位数是1974年，到确立的时间点的中位数是25年，到第一次临床试验的中位数是28年，到FDA批准的中位数是36年。在确定的时间点之前，没有任何产品获得批准，而在此时间点之前开始临床试验时，开发时间明显更长(11.5vs8.5年，p<；0.0005)。技术成熟是翻译过程中最长的阶段，对药物开发的效率有重要影响。
While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010–2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve) maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005). Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.