临床试验终点对外围状状克朗病的临床试验终点
Walter Reinisch1, Raja Atreya2, Florian Rieder3,4
1Clinical Department for Gastroenterology and Hepatology, Internal Medicine Clinic III, Medical University of Vienna, Vienna, Austria.
设计临床试验对周围囊性克罗恩病 (pCD) 需要标准化的终点. 未来的研究应该结合临床和放射学评估,以更好地评估新疗法.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验设计 临床试验设计
背景情况:
- 周围抽性克罗恩病 (pCD) 引起严重的症状并影响生活质量.
- 在随机对照试验 (RCT) 中缺乏验证的终点,阻碍了最佳治疗建议.
研究的目的:
- 审查对pCDRCT的考虑因素.
- 为PCD临床试验的当前终点提供专家意见.
主要方法:
- 在10个PCDIII/IV期RCT和后期分析中对初级终点的分析.
- 评估关闭,临床缓解和患者报告的结果.
主要成果:
- 对于临床囊反应/缓解,没有普遍的定义.
- 目前的终点缺乏验证,可重现性和最佳效果大小.
- 基于身体检查的评估是常见的,但未经验证.
结论:
- 未来的pCDRCT应该使用共同的初级临床和放射性评估.
- 标准化,客观的终点对于评估新疗法和改善患者治疗结果至关重要.
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