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期中分析：想说爱你，不容易！

2021年05月20日

来源：“国际临研”微信公众号

这是个真实的故事：

一个用了几年时间、耗费大量心血的研究，做了期中分析后，结果也是阳性的，但是投送到国际高分期刊，结果遇到不同的审稿人全体一致发出了关于期中分析的质疑，总结起来，审稿人的问题集中在以下几点点：

1.protocol 对期中分析只有简单一句话：到达60% 进行期中分析。为何看不到更多关于期中分析的详细信息？

2.谁做得期中分析，谁又做出了提前终止的决定？

看完以上审稿人的意见，你是否感觉和自己曾经的经历类似？

但是更多的问题来了，这可是一个非常好的阳性结果的文章啊，为啥这么好的阳性结果，投稿困难重重，再看看罗晟教授参与的研究，也是做完期中分析，投稿的，结果还是阴性的结果，可是接受的杂志是JAMA？

先来看看这个投稿困难重重的案例遇到的审稿人的问题究竟是什么？看完以上审稿人的意见，你是否感觉和自己曾经的经历类似？

The trial was stopped at the interim analysis. How was the stopping decision made? I don't see stopping rules in the protocol.

It is unclear to me why the investigators are publishing the results at this time. They cite a "planned interim analysis," but can the authors clarify whether there was a recommendation by a governing board to close the study? Has accrual ceased? This would typically be the process but the authors should describe it in the manuscript. If the investigators are going to continue to accrue patients, I am not sure why the manuscript is being published now. The protocol is also surprisingly limited in its description of interim analyses, with one sentence stating that the interim analysis will be performed when 68% of the patients are accrued.

Interim analyses, with proper statistical adjustments and plans, are used to facilitate the decisions (to Data Monitoring Committee, not the investigators in this case) whether the trial accrual should continue or stop early, with the necessary statistical rigor. However it does not provide an opportunity to report the trial findings prematurely while the accrual is ongoing. My suggestion to the investigators is to complete the study and resubmit the final analysis results.

该案例由于已提前终止研究，无法回头。

但面对国际审稿人提出的问题，未来我们应如何提前做好准备？

面对大量me too 的研究，如何改进才能突破me better ?

期中分析，想说爱你不容易！