划重点: 没有control group。 看得懂英文的好好读读

The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective.

“The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration.

“The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said.

Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.”

“For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said.
cannie 发表于 4/29/2020 9:34:27 AM [url=https://forums.huaren.us/showtopic.aspx?topicid=2541213&postid=83808675#83808675][img][/img][/url]

NIN的是双盲的吧。这个randomized的实验感觉只是不想浪费数据，既然有患者在用药，那就统计统计，起码得出用药5天和10天治疗效果无差别的结果，也没打算用这个试验的结果去跟FDA申请吧