Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review

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• 作者：Denis L. Jardim^a ; ^{jardimde@gmail.com} ; Eric S. Groves^b ; Philip P. Breitfeld^c ; Razelle Kurzrock^d
• 关键词：Drug development ; Precision medicine ; Phase III trials ; Biomarker ; FDA
• 刊名：Cancer Treatment Reviews
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：52
• 期：Complete
• 页码：12-21
• 全文大小：1252 K
• 卷排序：52

文摘

Drug development in oncology is characterized by a high rate of failure at the stage of phase III trials. Achieving proof of concept based on drug activity after a phase II trial increases the likelihood of later approval. Drugs developed under a biomarker-based selection strategy are less likely to fail at late stages of development.