【30秒重點】 癌症新藥上市不等於能多活很久,可以問醫師:這個藥能讓我多活多久? JAMA研究:2000到2016年FDA核准92個癌症新藥,共100個適應症、127個臨床試驗。 只有約51.2%是隨機試驗,74.8%是沒有盲性的開放性試驗。 這些藥物讓病人多活的中位數只有2.4個月。 2020/11/15 發表在美國醫學期刊 (JAMA): Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 | Clinical Pharmacy and Pharmacology | JAMA Network 摘要 過去17年 (2000~2016) 通過美國食品藥物管理局的92個癌症新藥,127個臨床試驗,核准100個適應症。次分析發現,屬於隨機臨床試驗(RCT)佔約一半(65; 51.2%),95個(74.8%)試驗並未維持盲性 (blinding),屬於開放性試驗。 重點來了,試驗發現這些藥物能讓病人平均「多」活多久?絕對中位數(Median)增加多少? 答案是: 2.4 個月。 Results Between 2000 and 2016, 92 novel cancer drugs were approved by the FDA for 100 indications based on data from 127 clinical trials. The 127 clinical trials included a median of 191 participants (interquartile range [IQR], 106-448 participants). Overall, 65 clinical trials (51.2%) were randomized, and 95 clinical trials (74.8%) were open label. Of 100 indications, 44 indications underwent accelerated approval, 42 indications were fo...