Prasad指出像Aquila这样的试验可能通过全球开展并以劣质护理作对照,人为制造总生存获益,而非对照真正的美国标准治疗。
因此唯一合适的研究是将早期治疗与当前标准治疗随机对照并测量生存。但这很困难,也不利于提升产品使用率,所以取巧的办法是把早期治疗与劣质护理对比——如果在全球范围开展试验,对照组会表现很差——就能轻松显示总生存获益。原文 (en)
So the only appropriate study would be to randomize to early treatment vs current standard of care, and measure survival. But that would be difficult, and make it hard to increase uptake for your product, so the easy cheat code is to randomize to early treatment vs poor care— if you run your trial globally the control arm will tank— then you can easily show a OS benefit.