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

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. We searched PubMed for phase III clinical trials published in New England Journal of Medicine (NEJM) and the Lancet 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. 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; p NEJM and the Lancet between 2019 and 2023 was lowest during 2020 to 2022 (n = 70–88) and highest in 2023 followed by 2019 (n = 110 and n = 96, respectively). 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. Timely publication of results from clinical studies supports healthcare professionals and patients and informs clinical practice. The World Health Organization recommends submission of the main findings of a clinical study to a journal within 12 months of trial completion. We searched for phase III cancer clinical trials published from 2019 to 2023 in two general medicine journals, The Lancet and the New England Journal of Medicine. We compared the duration of time from when data was available (this served as the start date) to the publication date between papers with and without medical writing support. Medical writing support, defined as support from a professional medical writer, was identified from the acknowledgements section of a paper. We identified a total of 164 papers reporting results from cancer studies. Most papers had medical writing support, 74%. Papers with medical writing support were published in an average of 10 months and papers without medical writing support were published in an average of 15 months. For papers with medical writing support, the time to publication was similar across calendar years. Similarly, the year of publication did not appear to affect time to publication for papers without medical writing support, although there were few papers identified in our analysis in 2020 and 2021. In conclusion, medical writing support is associated with timely publication of clinical trials, even during events such as the coronavirus disease 2019 pandemic.

专业医学撰稿人可协助科研作者合规且精准地发表科学研究成果。本研究假设，获得医学撰稿支持可推动研究成果的及时发表，并基于2019至2023年发表的III期肿瘤学临床试验论文，探讨二者的关联。鉴于本研究的时间跨度，我们同时将新型冠状病毒肺炎（COVID-19）大流行对发表量的影响作为次要研究目标进行评估。我们在PubMed数据库中检索了2019年1月1日至2023年12月31日期间发表于《新英格兰医学杂志》（NEJM）和《柳叶刀》（The Lancet）的III期临床试验论文。对报告肿瘤学试验的文献进行全文审阅，记录其是否致谢医学撰稿支持、数据截止日期、发表日期及其他关键特征。对比了有无医学撰稿支持的论文从数据截止到发表的时间间隔。本次检索共识别出442篇报告各类III期临床试验的论文，其中164篇（37%）为肿瘤学试验相关文献；122/164（74%）的文献披露了医学撰稿支持情况。披露医学撰稿支持的论文平均发表时间显著短于未披露的论文（307天 vs 466天；P<0.05）。2019至2023年发表于《新英格兰医学杂志》与《柳叶刀》的文献发表量在2020至2022年处于最低水平（70~88篇），2023年最高，其次为2019年（分别为110篇和96篇）。医学撰稿支持与临床试验结果的及时发表存在关联，即便在可能阻碍发表进程的事件（如COVID-19大流行）期间亦是如此。临床研究成果的及时发表可为医护人员与患者提供参考，并为临床实践提供依据。世界卫生组织建议，临床试验的主要研究结果应在试验完成后的12个月内提交至期刊。我们检索了2019至2023年发表于两本综合医学期刊《柳叶刀》与《新英格兰医学杂志》的III期肿瘤学临床试验论文。以数据可用之日为起始节点，对比了有无专业医学撰稿支持的论文从数据截止到发表的时间间隔。医学撰稿支持指来自专业医学撰稿人的协助，可通过论文的致谢部分进行识别。本次研究共识别出164篇报告肿瘤学研究结果的论文，其中74%获得了医学撰稿支持。获得医学撰稿支持的论文平均发表时长为10个月，未获得支持的论文平均发表时长为15个月。在获得医学撰稿支持的论文中，不同日历年度的发表时间间隔无显著差异；同理，未获得支持的论文的发表时间间隔亦未受发表年份的显著影响，尽管本研究在2020年与2021年识别到的文献数量较少。综上，即便在新型冠状病毒肺炎大流行这类可能干扰发表进程的事件期间，医学撰稿支持仍与临床试验的及时发表存在关联。