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评估在两家高影响力的普通医学期刊上,使用专业医学撰写人员是否与报告肿瘤学III期临床试验的论文发表时间相关。

Assessment of whether use of a professional medical writer is associated with time to publication of papers reporting phase III oncology clinical trials in two high-impact general medicine journals.

作者信息

Hammad Moamen, Carvell-Miller Thomas, Kerr Bernard, Moss Valerie

机构信息

Prime, London, UK.

出版信息

Curr Med Res Opin. 2025 May;41(5):887-893. doi: 10.1080/03007995.2025.2505697. Epub 2025 May 23.

Abstract

OBJECTIVE

Professional medical writers assist authors with ethical and accurate publication of scientific research. We hypothesized that the support of a medical writer would enable timely publication of research and explored their association using papers reporting phase III oncology trials from 2019-2023. Given the time frame of this research, we also assessed the impact of the coronavirus disease 2019 (Covid-19) pandemic on publication volume as a secondary objective.

METHODS

We searched PubMed for phase III clinical trials published in ( and the between 01/01/2019 and 12/31/2023. Publications reporting oncology trials were reviewed in full to document acknowledgement of medical writing support, data cut-off date, publication date and other key characteristics. Time from data cut-off to publication was compared for papers with and without medical writing support.

RESULTS

Our search identified 442 papers reporting any phase III clinical trials, of which 164 (37%) reported oncology trials; 122/164 (74%) disclosed medical writing support. Mean time to publication was significantly shorter for papers disclosing medical writing support than those without (307 vs. 466 days;  < 0.0001). Median time to publication for papers with medical writing support appeared stable from 2019 to 2023. The volume (oncology and non-oncology) of phase III trials published in and the between 2019 and 2023 was lowest during 2020 to 2022 ( = 70-88) and highest in 2023 followed by 2019 ( = 110 and  = 96, respectively).

CONCLUSIONS

Medical writing support is associated with timely publication of clinical trial results, even during events that may disrupt publication development such as the Covid-19 pandemic.

摘要

目的

专业医学撰写人员协助作者进行科学研究的伦理和准确发表。我们假设医学撰写人员的支持能够使研究及时发表,并利用2019年至2023年报告III期肿瘤学试验的论文探讨了它们之间的关联。鉴于本研究的时间范围,我们还将2019冠状病毒病(Covid-19)大流行对发表量的影响作为次要目标进行了评估。

方法

我们在PubMed中检索了2019年1月1日至2023年12月31日期间发表的III期临床试验。对报告肿瘤学试验的出版物进行了全面审查,以记录对医学撰写支持的认可、数据截止日期、发表日期和其他关键特征。比较了有和没有医学撰写支持的论文从数据截止到发表的时间。

结果

我们的检索共识别出442篇报告任何III期临床试验的论文,其中164篇(37%)报告肿瘤学试验;122/164(74%)披露了医学撰写支持。披露医学撰写支持的论文的平均发表时间显著短于未披露的论文(307天对466天;<0.0001)。2019年至2023年,有医学撰写支持的论文的中位发表时间似乎保持稳定。2019年至2023年期间在和发表的III期试验的数量(肿瘤学和非肿瘤学)在2020年至2022年期间最低(=70-88),2023年最高,其次是2019年(分别为=110和=96)。

结论

医学撰写支持与临床试验结果的及时发表相关,即使在可能扰乱发表进程的事件期间,如Covid-19大流行。

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