The probability that a drug entering clinical trials will gain approval from the US Food and Drug Administration has dropped from 23.9% in 1997 to 10.4% today. While the first recombinant insulin in the 1980’s took less than a decade from testing to approval, monoclonal antibodies and gene therapy took more than 20 years to reach the same milestone.
这一现象的根源在于药品失败率极高以及技术周期极长。进入临床试验的药品获得美国食品和药品监督局（Food and Drug Administration）批准的概率从1997年的23.9%下降至如今的10.4%。20世纪80年代，第一个合成胰岛素花了不到十年的时间走完了从测试到批准的过程，但单株抗体和基因疗法却用了20多年才抵达了同样的目的地。