摘要
面对肿瘤患者高度未满足的临床需求,各国管理当局都愿意采用更加灵活的方式来加快有效抗肿瘤新药的上市。我国也一直在努力探索符合当前现实国情的方式方法。
If the confirmatory trial shows that the drug actually provides a clinical benefit, and the precondition for surrogate endpoints on the scientific support can be satisfied, accelerated approval and conditional approval are adopted by regulators in various countries for cancer drugs that obtaining data on clinical outcomes can take a long time. The actual situation of cancer incidences and R&D of cancer drugs in China should be considered by SFDA.
出处
《中国处方药》
2010年第2期10-12,共3页
Journal of China Prescription Drug
