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不完整的毒性报告和在III期瘤学试验中使用毒性最小化的语言
Avital M Miller1, Adina H Passy1, Alexander D Sherry1
1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
JCO oncology practice
|January 8, 2025
概括
在第三阶段瘤学试验中缺乏完整的毒性报告 (CTR),经常使用主观毒性最小化语言 (TML). 工业赞助的试验显示出比合作小组试验更好的毒性报告.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 医学研究伦理学医学研究伦理学
背景情况:
- 准确报告治疗毒性对于在瘤学中做出明智的临床决策至关重要.
- 第三期瘤学试验对于评估新的癌症疗法至关重要.
- 不完整的毒性数据和最小化的语言可能会掩盖治疗风险.
研究的目的:
- 评估第三阶段瘤学试验中完整毒性报告 (CTR) 的程度.
- 评估使用毒性最小化语言 (TML) 的流行率和模式.
- 为了比较行业赞助和合作集团赞助的试验之间的毒性报告实践.
主要方法:
- 2002年至2020年期间发表的双臂优势设计III期瘤学试验的系统审查.
- 基于报告总不良事件 (TAE),严重不良事件 (SAE),死亡和因毒性而停止治疗的定义CTR.
- 定义TML为主观淡化治疗危害的语言.
主要成果:
- 在407项试验中,只有32%符合CTR标准,55%报告TAE.
- 与合作集团赞助的试验相比,行业赞助的试验显示了显著更高的CTR (37%) 与合作集团赞助的试验相比 (4%).
- 在46%的试验中使用TML,而不考虑赞助或其他试验因素.
结论:
- 在III期瘤学试验中的毒性报告经常不完整,并且经常使用最小化语言.
- 工业赞助与更全面的毒性报告有关.
- 标准化毒性报告对于改善对新癌症治疗方法的理解至关重要.
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