在III期瘤学试验中,二次终点利用率和出版率
Esther J Beck1, Alexander D Sherry1, Marcus A Florez2
1Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
瘤学试验中的二次终点 (SEP) 越来越常见,但不一致地发表. 加重患者负担的SEP,像PRO一样,显示较低的出版率,影响试验透明度.
科学领域:
- 瘤学 临床试验 临床试验
- 生物统计学 生物统计学
- 科学出版物 科学出版物
背景情况:
- 二级终点 (SEP) 对于解释临床试验结果至关重要,但其特征和出版模式仍然不清楚.
- 了解SEP的使用和发布对于评估试验数据的完整性至关重要.
研究的目的:
- 在晚期瘤学试验中实证地描述SEP的范围和出版率.
- 为了确定与SEP出版率相关的因素.
主要方法:
- 随机发布的第三期瘤学试验及其相关的ClinicalTrials.gov条目和协议的分析.
- 后勤回归用于评估试验特征与SEP出版率之间的关联.
- 280项试验的查,包括244576名患者和2562名SEP.
主要成果:
- 只有22%的试验在clinicaltrials.gov和协议之间显示一致的SEP列表.
- 每项试验的SEP数量随着时间的推移而增加,由行业赞助的试验具有更多的SEP.
- 总体而言,69%的SEP已公布,按类别有很大的差异.
- 患者报告的结果 (63%) 和翻译相关结果 (44%) 的发表率较低.
- 有更多SEP的试验与较低的整体SEP出版率有关.
结论:
- 晚期瘤学试验中的SEP出版率高度可变,取决于终点类型.
- 观察到患者负担的SEP的出版不足,如患者报告的结果和翻译相关值.
- 试验人员应在试验设计过程中考虑SEP的相关性和可行性,以确保透明度并最大限度地降低患者负担.
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