Satoshi Funada, Yan Luo, Yuki Kataoka, Takashi Yoshioka, Yusuke Fujita, Shinya Yoshida, Morihiro Katsura, Masafumi Tada, Norihiro Nishioka, Yoshiaki Nakamura, Kentaro Ueno, Ryuji Uozumi, Toshi A Furukawa
OBJECTIVES: In anticancer clinical trials, particularly open-label trials, central reviewers are recommended to evaluate progression-free survival (PFS) and objective response rate (ORR) to avoid detection bias of local investigators. However, it is not clear whether the bias has been adequately identified, or to what extent it consistently distorts the results. Therefore, the objective of this study was to evaluate the detection bias in oncological open-label trials by confirming whether local investigators overestimate the PFS and ORR compared with the findings of central reviewers...
August 16, 2023: BMJ Evidence-Based Medicine