肿瘤临床试验中的专业医学作家协助。
Professional Medical Writer Assistance in Oncology Clinical Trials.
机构信息
The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Baylor College of Medicine, Houston, Texas, USA.
出版信息
Oncologist. 2020 Nov;25(11):e1812-e1815. doi: 10.1634/theoncologist.2020-0406. Epub 2020 Sep 17.
BACKGROUND
The use of professional medical writers (PMWs) has been historically low, but contemporary data regarding PMW usage are scarce. In this study, we sought to quantify PMW use in oncologic phase III randomized controlled trials (RCTs).
METHODS
We performed a database query through ClinicalTrials.gov to identify cancer-specific phase III RCTs; we then identified whether a PMW was involved in writing the associated trial manuscript reporting primary endpoint results.
RESULTS
Two-hundred sixty trials of 600 (43.3%) used a PMW. Industry-funded trials used PMWs more often than nonindustry trials (54.9% vs. 3.0%, p < .001). Increased PMW usage was further noted among trials meeting their primary endpoint (53.4% vs. 32.9%, p < .001) and trials that led to subsequent Food and Drug Administration approval (63.1% vs. 36.3%, p < .001). By treatment interventions, PMW use was highest among systemic therapy trials (50.2%). Lastly, the use of PMWs increased significantly over time (odds ratio: 1.11/year, p = .001).
CONCLUSION
PMW use rates are high among industry-funded trials. We urge continued and increased transparency in reporting the funding and use of PMWs.
背景
专业医学作家（PMW）的使用历史上一直较低，但关于 PMW 使用的当代数据却很少。在这项研究中，我们试图量化肿瘤学 III 期随机对照试验（RCT）中 PMW 的使用情况。
方法
我们通过 ClinicalTrials.gov 进行了数据库查询，以确定特定于癌症的 III 期 RCT；然后，我们确定是否有 PMW 参与撰写相关试验手稿报告主要终点结果。
结果
在 600 项试验中有 260 项（43.3%）使用了 PMW。工业资助的试验比非工业试验更频繁地使用 PMW（54.9%对 3.0%，p <.001）。在达到主要终点的试验（53.4%对 32.9%，p <.001）和导致随后获得美国食品和药物管理局批准的试验（63.1%对 36.3%，p <.001）中，PMW 的使用进一步增加。按治疗干预措施，PMW 在系统治疗试验中使用最多（50.2%）。最后，PMW 的使用随着时间的推移显著增加（优势比：1.11/年，p =.001）。
结论
工业资助的试验中 PMW 的使用率很高。我们敦促在报告 PMW 的资金和使用情况方面继续保持并增加透明度。
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