Use of suboptimal control arms in randomized clinical trials of investigational cancer drugs in China, 2016-2021: An observational study.
Yichen ZhangDingyi ChenSiyuan ChengZhizhou LiangLu YangQian LiLin BaiHuangqianyu LiWei LiuLuwen ShiXiaodong GuanPublished in: PLoS medicine (2023)
In this study, over one-eighth of randomized trials of cancer drugs registered to apply for regulatory approval in China used a suboptimal comparator. Our results highlight the necessity to refine the design of randomized trials to generate optimal clinical evidence for new cancer therapies.