Expert Opin Drug Discov. 2013 Apr;8(4):363-8. doi: 10.1517/17460441.2013.768984. Epub 2013 Feb 4.
Attrition is a major issue in anticancer drug development with up to 95% of drugs tested in Phase I trials not reaching a marketing authorisation making the drug development process enormously costly and inefficient. It is essential that this problem is addressed throughout the whole drug development process to improve efficiency which will ultimately result in increased patient benefit with more profitable drugs. The approach to reduce cancer drug attrition rates must be based on three pillars. The first of these is that there is a need for new pre-clinical models which can act as better predictors of success in clinical trials. Furthermore, clinical trials driven by tumour biology with the incorporation of predictive and pharmacodynamic biomarkers would be beneficial in drug development. Finally, there is a need for increased collaboration to combine the unique strengths between industry, academia and regulators to ensure that the needs of all stakeholders are met.
在抗癌药物开发中,损耗是一个主要问题,高达 95%的在 I 期临床试验中测试的药物未能获得营销授权,这使得药物开发过程变得非常昂贵和低效。从整个药物开发过程着手解决这个问题以提高效率至关重要,这最终将使更多有利可图的药物为患者带来更大的益处。降低抗癌药物损耗率的方法必须基于三个支柱。首先,需要新的临床前模型,这些模型可以更好地预测临床试验的成功。此外,基于肿瘤生物学的临床试验,结合预测和药效动力学生物标志物,将有助于药物开发。最后,需要加强合作,将工业、学术界和监管机构的独特优势结合起来,以确保满足所有利益相关者的需求。