Neuroscience and Pain Research Unit, Worldwide Research & Development, Pfizer Inc., Cambridge, Massachusetts, USA.
Clin Pharmacol Ther. 2018 Feb;103(2):193-195. doi: 10.1002/cpt.901. Epub 2017 Oct 27.
The probability of achieving marketing approval of a novel therapeutic for psychiatric indications is extremely low due largely to the inability to demonstrate durable and reproducible efficacy in phase II trials and beyond. These failures are often attributed to the lack of translation of the underlying neuropharmacology from animal model(s) to the disease population. However, how assured is such a conclusion considering the clinical efficacy path rarely meticulously parallels the preclinical experiment(s) that underwrote it?
由于在 II 期临床试验及之后阶段无法证明持久和可重现的疗效,新型精神治疗药物获得营销批准的可能性极低。这些失败通常归因于未能将潜在的神经药理学从动物模型转化到疾病人群。然而,考虑到临床疗效途径很少与支持它的临床前实验精确平行,这样的结论有多大把握呢?