终止和不公布宫颈癌或癌前病变随机对照试验。

IF 1.9 4区 医学 Q3 ONCOLOGY Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI:10.1093/jjco/hyae096
Dongfang Lu, Xiaolin Chen, Yanmin Mu, Lingxiao Kong, Ling Zhang, Juan Li
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引用次数: 0

摘要

背景:在临床试验中,研究浪费是一个相当大的问题,而未公开是其中一个重要原因。我们旨在确定有关宫颈癌或癌前病变的随机对照试验(RCT)终止和未公开的普遍程度:我们在 ClinicalTrials.gov 上搜索了 2000 年 1 月至 2020 年 12 月间开始的研究宫颈癌或癌前病变的注册 RCT。主要和次要结果分别为试验未发表和过早终止。通过使用 PubMed 和 Scopus 数据库对同行评审期刊进行系统检索来确定发表情况:共有 113 项研究性试验符合纳入标准。在2020年12月之前完成的85项试验中,有44项(51.8%)提前终止,40项(47.1%)未发表。单中心设计(61.4% vs. 34.1%,P = .012)和缺乏外部资助(59.1% vs. 36.6%,P = .038)与试验中止有显著相关性。大规模试验(目标样本量大于400;46.7% vs. 17.5%,P = .004)和外部资助试验(66.7% vs. 35.0%,P = .004)更有可能发表。多变量逻辑分析显示,样本量大[奇数比(OR):4.125,95% 置信区间(CI):1.511-11.259,P = .006]和有外部资助(OR:3.714,95% CI:1.513-9.117,P = .004)是试验发表的独立积极因素:结论:相当一部分与宫颈癌或癌前病变有关的研究性试验提前终止或仍未发表,造成了研究资源的浪费。
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Discontinuation and non-publication of randomized controlled trials on cervical cancer or precancer.

Background: Research waste is a considerable problem in clinical trials, with nonpublication being a significant contributor. We aimed to determine the prevalence of discontinuation and nonpublication of randomized controlled trials (RCTs) on cervical cancer or precancer.

Methods: We searched ClinicalTrials.gov for registered RCTs investigating cervical cancer or precancer that started between January 2000 and December 2020. The primary and secondary outcomes were trial nonpublication and premature discontinuation, respectively. Publication status was determined by systematic searches of peer-reviewed journals using the PubMed and Scopus databases.

Results: A total of 113 RCTs met the inclusion criteria. Among the 85 trials completed before December 2020, 44 (51.8%) were prematurely discontinued and 40 (47.1%) were unpublished. A single-center design (61.4% vs. 34.1%, P = .012) and lack of external funding (59.1% vs. 36.6%, P = .038) were significantly associated with trial discontinuation. Large-scale (target sample size >400; 46.7% vs. 17.5%, P = .004) and externally funded trials (66.7% vs. 35.0%, P = .004) were more likely to be published. Multivariate logistic analysis revealed that a large sample size [odd ratio (OR): 4.125, 95% confidence interval (CI): 1.511-11.259, P = .006] and presence of external funding (OR: 3.714, 95% CI: 1.513-9.117, P = .004) were independent positive factors for trial publication.

Conclusion: A significant proportion of RCTs related to cervical cancer or precancer were discontinued early or remain unpublished, resulting in a waste of research resources.

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来源期刊
CiteScore
3.70
自引率
8.30%
发文量
177
审稿时长
3-8 weeks
期刊介绍: Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region. JJCO publishes various articles types including: ・Original Articles ・Case Reports ・Clinical Trial Notes ・Cancer Genetics Reports ・Epidemiology Notes ・Technical Notes ・Short Communications ・Letters to the Editors ・Solicited Reviews
期刊最新文献
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