评估在与质母细胞瘤相关的临床试验中遵守报告任务
Nicholas Kendall1, Julian S Rechberger2, Abdelrahman M Hamouda2
1The University of South Dakota Sanford School of Medicine, Vermillion, South Dakota, United States of America.
PloS one
|May 16, 2025
概括
质母细胞瘤试验报告的遵守率很低,只有13%的人达到12个月的截止日期. 生物干预和早期试验阶段等因素与五年内报告延迟有关.
科学领域:
- 临床研究伦理学
- 在瘤学瘤学.
- 临床试验报告报告
背景情况:
- 准确和及时的科学报告对于临床研究伦理至关重要.
- ClinicalTrials.gov要求进行临床试验登记和结果报告.
- 遵守FDA的12个月报告窗口特别低.
研究的目的:
- 在clinicaltrials.gov.gov上评估质母细胞瘤 (GBM) 试验报告率.
- 确定与GBM试验报告不合规相关的因素.
主要方法:
- 在clinicaltrials.gov.gov上使用算法来识别强制性GBM试验.
- 收集关于试验特征的数据,包括阶段,干预和设计.
- 使用卡普兰-梅尔分析和考克斯回归来评估报告时间和相关因素.
主要成果:
- 255个GBM试验被确定为可能被授权报告.
- 只有13%的试验在12个月的最后期限内报告;82.7%的试验在五年内报告.
- 生物干预,1-2期试验和四重掩护与较低的五年报告率有关.
结论:
- 不遵守报告任务是GBM试验的一个重要问题.
- 虽然没有任何因素影响了12个月的报告,但有几个因素影响了五年报告.
- 需要进一步的研究来了解这些协会,并改善及时报告.
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