影响系统性硬化症累积率的试验级因素随机临床试验随机临床试验
Barbara Russo1, Iulia-Simona Chirică2, Delphine Sophie Courvoisier3
1Division of Dermatology and Venereology, University Hospitals of Geneva, Geneva, Switzerland.
Seminars in arthritis and rheumatism
|May 11, 2025
概括
系统性硬化症 (SSc) 随机对照试验 (RCT) 的患者入学速度缓慢,平均需要15个月. 诸如国际合作和包括两种SSc亚型等因素可以提高患者招募率.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 系统性硬化症研究研究
背景情况:
- 系统性硬化症 (SSc) 患者在临床试验中的招生存在重大挑战.
- 了解影响积累率的因素对于推进SSc研究至关重要.
研究的目的:
- 估计SSc随机对照试验 (RCT) 中患者入学的平均时间.
- 在SSc RCT中确定与患者累积率相关的关键因素.
主要方法:
- 系统搜索PubMed索引的SSc-RCTs (2000-2024年) 与大流行前的招聘.
- 提取关于试验特征和入学时间的数据.
- 多变量负二项式通用线性模型用于分析积累率决定因素.
主要成果:
- 平均招募时间为15个月 (IQR 9.9-30.0),平均积累率为每月3.1名参与者.
- 积累率呈现波动,在2000年代初和2012年后,招聘速度更快.
- 发现了倾斜的随机化,盲目化,非行业资金,国际招聘以及包括有限和扩散的SSc亚型的积极关联.
结论:
- 系统性硬化症患者被招募参加RCT仍然是一个重大障碍.
- 在过去的二十年中,积累率没有显示出持续的改善.
- 优化试验设计,如国际合作和更广泛的患者纳入,可以提高SSc RCT积累.
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