Department of Epidemiology and Biostatistics, University of California, San Francisco.
JAMA Netw Open. 2023 Feb 1;6(2):e2254405. doi: 10.1001/jamanetworkopen.2022.54405.
The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated.
To assess characteristics of oncology trials that use medical writers and whether there is an association between the use of medical writers and trial success or the primary outcome evaluated.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included oncology trials testing a tumor-targeting intervention that were published in The Lancet, The Lancet Oncology, JAMA, JAMA Oncology, Journal of Clinical Oncology, and The New England Journal of Medicine between May 1, 2021, and May 1, 2022.
Assistance of medical writers or no assistance.
The main outcomes were the percentage of studies with medical writers, the percentage of trial successes reported with medical writers, the association between trial success and medical writer use, and the association between a primary end point and medical writer use.
Among 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. Of the studies that included a medical writer, 83 (58.9%) were successful. Of the studies that did not include a medical writer, 64 (49.6%) were successful (P = .16 for difference). Studies with medical writers were less likely than studies without medical writers to have the end point of overall survival (15 [10.6%] vs 17 [13.2%]) and disease-free or event-free survival (16 [11.3%] vs 29 [22.5%]), whereas studies with a medical writer were more likely to have the end point of progression-free survival (32 [22.7%] vs 17 [13.2%]). Use of medical writer was associated with the conclusions being presented favorably in all studies (113 [80.1%] vs 89 [69.0%]; odds ratio [OR], 1.81 [95% CI, 1.04-3.19]), but when adjusted for other variables, there was no association (OR, 1.84 [95% CI, 0.92-3.72]).
In this cross-sectional study, trials using medical writers were more likely to report surrogate end points, such as progression-free survival, and favorable conclusions, but when adjusted for trial phase, randomization, and study funding, there was no association with favorable conclusions. These findings suggest that journals need heightened scrutiny for studies with medical writers and that authorship should be properly acknowledged.
使用医学作者来传达科学信息的做法已经很普遍，但它可能会影响信息的传达方式和内容。
评估使用医学作者的肿瘤学试验的特征，以及医学作者的使用与试验成功或评估的主要结局之间是否存在关联。
设计、设置和参与者：这项横断面研究包括在 2021 年 5 月 1 日至 2022 年 5 月 1 日期间在《柳叶刀》、《柳叶刀肿瘤学》、《美国医学会杂志》、《美国医学会肿瘤学杂志》、《临床肿瘤学杂志》和《新英格兰医学杂志》上发表的、测试肿瘤靶向干预措施的肿瘤学试验。
医学作者的协助或无协助。
主要结局是有医学作者参与的研究的百分比、有医学作者参与的研究报告的成功率、试验成功与医学作者使用之间的关联，以及主要终点与医学作者使用之间的关联。
在 270 项研究中，有 141 项（52.2%）包括医学作者，129 项（47.8%）不包括医学作者。在有医学作者参与的研究中，有 83 项（58.9%）是成功的。在没有医学作者参与的研究中，有 64 项（49.6%）是成功的（差异无统计学意义，P=0.16）。有医学作者参与的研究比没有医学作者参与的研究更不可能出现总生存（15 [10.6%] 与 17 [13.2%]）和无疾病或无事件生存（16 [11.3%] 与 29 [22.5%]）终点，而有医学作者参与的研究更有可能出现无进展生存（32 [22.7%] 与 17 [13.2%]）终点。使用医学作者与所有研究中报告有利结论有关（113 [80.1%] 与 89 [69.0%]；优势比 [OR]，1.81 [95%CI，1.04-3.19]），但在调整其他变量后，两者之间没有关联（OR，1.84 [95%CI，0.92-3.72]）。
在这项横断面研究中，使用医学作者的试验更有可能报告替代终点，如无进展生存和有利结论，但当调整试验阶段、随机化和研究资金后，与有利结论之间没有关联。这些发现表明，期刊需要对有医学作者参与的研究进行更严格的审查，并且作者身份应该得到适当的承认。
