Journal of Clinical Trials
Open Access

Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical Col, Beijing 100021, China

Publications

• Research Article   
  General Principles and Confirmatory Trial Design of the Co-Development of Anticancer Drugs for Use in Combination
  Author(s): Huiyao Huang, Yu Tang, Dandan Cui, Xinyu Meng, Dawei Wu, Meiruo Liu, Shuhang Wang, Xiyan Li, Xin Wang, Yue Yu, Lanwei Guo, Yuan Fang, Ning Jiang, Huilei Miao, Peiwen Ma, Bing he Xu and Ning Li*
  
  The emergence of immunotherapy has caused a wave of co-development of anticancer drugs globally, and some unreasonable or unwarranted combination of anticancer drugs was observed. Combining regulatory guidance with case studies, this study aims to clarify key generally applicable principles in the co-development of combination therapy, when it’s appropriate to start a confirmatory trial, possible scenarios and main determinants of the most efficient confirmatory trial design. Biological rationale for the combination, adequate safety profile of each individual drug and the combination, added efficacy of the combination and attribution of each individual drug, are three golden basic principles for anticancer combination therapy. Before initiation of a confirmatory trial, a powered factorial study supporting the superiority of the combination over individual dr.. View More»
  DOI: 10.35248/2167-0870.22.12.513

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