在炎症性肠病临床试验中检测结直肠瘤的考虑因素
Mira M Yang1, Keith Usiskin1, Harris A Ahmad1
1Division of Immunology and Fibrosis Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Digestive diseases (Basel, Switzerland)
|September 27, 2023
概括
在炎症性肠病 (IBD) 试验中,高质量的结肠镜有助于早期检测结肠直肠瘤. 赞助商,内镜师和读者之间的合作对于最大限度地提高癌症识别和患者安全至关重要.
科学领域:
- 胃肠病学 胃肠病学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 高质量的结肠镜监测可以改善在炎症性肠病 (IBD) 患者的结肠直肠瘤的早期检测.
- 在IBD临床试验中的内镜评估疾病活动和瘤监测.
研究的目的:
- 在IBD临床试验中概述结直肠癌识别的最佳实践.
- 定义参与IBD临床试验监督的所有利益相关者的角色和责任.
主要方法:
- 对IBD内镜监测现行实践和指导方针的审查.
- 强调标准化的成像程序和协议设计.
- 临床试验赞助商,现场内镜师和中央阅读团队之间的合作框架.
主要成果:
- 有效的协作对于最大限度地提高发育不良的检测至关重要.
- 现场内镜师在患者特定的程序量身定制和初步评估中发挥着关键作用.
- 中央阅读小组对于检测瘤至关重要,需要一个报告框架.
结论:
- 最佳实践需要赞助商,内镜师和读者之间的参与,以便在IBD试验中最佳地识别结直肠癌.
- 标准化程序,患者保护和赞助商的持续监督至关重要.
- 协同的团队合作增强了内镜评估和瘤检测,改善了患者的治疗结果.
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