肿瘤临床试验中不良事件通用术语标准的患者报告结果版本的使用

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-09-02 DOI:10.1016/j.conctc.2025.101547

Lauren Rogak , Jamie K. Forschmiedt , Ethan Basch , Gina L. Mazza , Minji K. Lee , Eric A. Meek , Brenda Ginos , Blake T. Langlais , Brie N. Noble , Allison M. Deal , Claire Yee , Gita Thanarajasingam , Amylou C. Dueck

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引用次数: 0

摘要

不良事件通用术语®（PRO-CTCAE®）项目库的患者报告结果版本使患者能够在癌症临床试验中自我报告症状。它是作为CTCAE v4.0的伙伴开发的。本分析的目的是了解PRO-CTCAE自发布以来的使用情况。使用PRO-CTCAE的试验已在clinicaltrials.gov上确认。对试验特征进行描述性分析。使用泊松回归对发布在clinicaltrials.gov上的年度试验数量进行了增加趋势测试。在327项确定的试验中，318项（97%）为肿瘤学试验，269项（82%）为介入性试验，170项（52%）为随机试验。试验数量随时间显著增加（P < .001）。自发布以来，PRO-CTCAE在肿瘤学试验中有了大量且不断增长的应用。

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Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials

The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (P < .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.