查失败和炎症性肠病的原因随机对照试验:一项对16913名查患者的研究
Mathieu Uzzan1, Georgi Georgiev2, Laurent Peyrin-Biroulet3
1Paris Est Créteil University UPEC, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Gastroenterology Department, Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Créteil, France.
在炎症性肠病 (IBD) 临床试验中,特别是克罗恩病 (CD) 中,高屏失败率阻碍了患者的招募. 严格的资格标准是主要障碍,影响试验成功.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验管理 临床试验管理
- 患者招募 患者招募
背景情况:
- 炎症性肠病 (IBD) 试验的招聘率正在下降.
- 在IBD中招募率低和高屏幕失败 (SF) 的原因尚不清楚.
研究的目的:
- 在IBD2期和3期临床试验中评估查失败比例并确定潜在原因.
主要方法:
- 分析了17项随机对照IBD试验中的SF数据 (12例性结肠炎,5例克罗恩病).
- 使用曼·惠特尼和费舍尔测试进行统计分析,以比较患者组.
主要成果:
- 在性结肠炎 (UC) 试验中,SF的平均比例为43%,在克罗恩病 (CD) 试验中为53%.
- 主要的SF原因:不符合梅奥得分 (UC) 和CDAI标准 (CD).
- 在CD试验中,SF比例明显高于UC试验 (P=.027).
结论:
- 高的SF率,特别是在CD试验中,阻碍了IBD研究的患者招募.
- 任意的临床和内镜适用性标准是临床试验入学的重要限制因素.
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