Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Biostatistics and Data Sciences, Boehringer Ingelheim (China) Investment Co. Ltd., Shanghai 201203, China
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