Dr. I-Chen Tsai蔡依橙醫師Research Mentoring研究指導室

My mentor has a new treatment, but the series is single-arm and small. How can I write it up?

I-Chen Tsai, MD, PhDTranslated from InnovaRad's public Q&A (Taiwan)Original published Nov 17, 2022Read the original
The question. My mentor has a new treatment that combines two existing treatments. There are only nine patients so far, and the outcomes look good. He wants me to write it up. But it is single-arm and the numbers are small. Is there a good angle? Many people are interested in this topic, but there are no definitive results yet. There are only registered clinical trials that have not reported, and no other original articles.

Hearing only the first half, I thought it would not work. After hearing the second half, I think it has a good chance. Here is why.

Most of the time, when a mentor hands us a series of patients treated one way and says, "Go run some statistics," the result is not good. The usual problems are that the treatment has not kept up with the field, the protocol has problems, and the number of patients is not clearly large. A quick PubMed search usually shows this.

A single-arm study is the weakest kind of clinical study, because it can never fully answer the reviewer's suspicion that you are simply praising your own product. Maybe your few patients happened to respond well. Who knows whether the treatment would work as well in my hospital?

But you say the treatment is very new and many people are interested. Then you have a good chance. In the early days of a field, people want to hear any information.

You could write it as a clinical feasibility study, emphasizing feasibility and reporting that there were no serious adverse effects. As for outcomes, compare them with other published studies in the Discussion.

Or you could call it a preliminary study or early experience. If the medical community is truly interested, that also works.

A control group is important and powerful. But science has always had another line, without control groups. The discovery of the structure of DNA and Darwin's theory of evolution, for example, did not rely on controlled studies, and the world still accepted them.

這些回答是經驗與建議,不是規定。你的稿件以目標期刊的規定為準,你的研究以所屬機構的倫理審查為準。