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关于在炎症性肠病临床试验中扩大资格标准的建议
Corey A Siegel1, Victoria Rai2, An Outtier3
1Inflammatory Bowel Disease Program, Section of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, NH.
招募炎症性肠病 (IBD) 临床试验是困难的. 新的建议旨在扩大资格标准,使试验对代表性患者群体更加包容和高效.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验设计 临床试验设计
- 患者招募 患者招募
背景情况:
- 针对炎症性肠病 (IBD) 的临床试验招聘面临越来越多的挑战.
- 需要改善患者人群代表性和试验效率.
研究的目的:
- 制定专家支持的建议,以扩大IBD临床试验的资格标准.
- 增强患者的包容性和简化试验时间表.
主要方法:
- 使用了RAND/UCLA适当性方法.
- 在7个领域的文献综述中,得到了32个陈述.
- 国际IBD专家对声明的适当性和可行性进行了投票,随后进行了调节的讨论和第二轮投票.
主要成果:
- 完成了26项建议,其中25项被评为适当的,所有建议都是可行的.
- 关键建议包括复杂表型的包容性,自由的安全标准,使用非侵入性生物标志物,尽量减少洗期,灵活的药物史要求,接受最近的结肠镜检查,以及不那么严格的年龄限制.
结论:
- 扩大IBD临床试验资格被认为是适当和可行的.
- 国际专家的高度共识支持这些建议,以提高试验的包容性和效率.
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