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关于制定一次性硬化性胆管炎临床试验的核心成果集的议定书

Nasir Hussain^1,2, Christopher Ma³, Gideon Hirschfield⁴

¹NIHR Birmingham Biomedical Research Centre, Birmingham, UK.

|June 26, 2024

概括

为初级硬化性胆道炎 (PSC) 试验开发核心结果集 (COS) 对于标准化结果指标至关重要. 这种协调的方法将改善对这种进展性肝病的新疗法的评估.

科学领域:

肝病学肝病学是一种肝病学.
临床试验方法论临床试验方法论
结果测量结果测量

背景情况:

初级硬化性胆道炎 (PSC) 是一种免疫媒介的肝病,目前没有治疗方法来减缓进展.
针对PSC的临床试验面临挑战,原因是异质的结果措施和不断变化的治疗目标.
需要在PSC研究中标准化结果评估.

研究的目的:

开发一套基于共识的核心结果集 (COS) 进行一次性硬化性胆管炎 (PSC) 临床试验.
协调评估新型PSC疗法的结果措施.
提高PSC临床试验结果的可靠性和可比性.

主要方法:

系统的文献审查以确定现有的PSC试验结果.
与各种利益相关者 (患者,临床医生,行业,付款人) 进行定性访谈.
国际双轮德尔菲调查以确定结果优先级.
达成共识的会议最终确定了COS.

主要成果:

该研究概述了一种多阶段的方法,用于开发特定于PSC的COS.
这个过程涉及文献审查,利益相关者参与,德尔菲调查和共识建设.
由此产生的COS旨在在未来的PSC试验中标准化结果测量.

结论:

一个协调的核心结果集对于推进PSC临床试验评估至关重要.
标准化结果将有助于对新的治疗干预措施进行更可靠的评估.
开发的COS将有助于比较试验结果,并为临床决策提供信息.

关键词:

胃肠道学胃肠道学肝胆道疾病是一种肝胆道疾病.肝胆道手术是肝胆道的手术.肝病学肝病学是一种肝病学.炎症性肠病是一种炎症性肠病.患者报告的结果措施

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