Learning from sotorasib: risk of bias in confirmatory clinical studies of accelerated approved drugs and resolution strategies

BMC Med. 2024 May 20;22(1):202. doi: 10.1186/s12916-024-03414-y.

¹ Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing, 100021, People's Republic of China.
² Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing, 100021, People's Republic of China. snowflake201@gmail.com.
³ Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing, 100021, People's Republic of China. ncctrials@cicams.ac.cn.

^# Contributed equally.

No abstract available

Keywords: Accelerated approved drugs; Clinical trial; Resolution strategy; Sotorasib; Systemic bias.

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