医学
食品药品监督管理局
代表性启发
临床终点
人口
临床试验
选择偏差
加药
重症监护医学
内科学
药理学
环境卫生
心理学
社会心理学
病理
作者
Kerrington Powell,Michael C. Burns,Vinay Prasad
标识
DOI:10.1016/j.eururo.2022.08.029
摘要
We highlight concerns regarding the approval of relugolix for patients with prostate cancer. These include the unsuitable comparator arm and primary endpoint in the HERO trial, as well as potential selection bias and the poor representativeness of the trial population. Dosing adherence to a daily tablet may also be an issue in comparison to injections at 3-mo intervals. Rigorous postmarketing trials of relugolix assessing clinically meaningful endpoints for these patients are needed.
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