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解决葡萄牙加强临床研究的挑战:来自OncoT3专家组德尔菲研究的见解

Catarina Resende¹, Marta Abreu², José Presa Ramos³

¹Medicine, University of Coimbra, Agencia de Investigação Clínica e Inovação Biomédica (AICIB), Coimbra, PRT.

|December 16, 2024

概括

德尔菲研究确定了优化葡萄牙临床研究的关键领域,在45个陈述上达成专家共识. 在患者招募和对临床试验的机构支持方面仍然存在挑战.

科学领域:

临床研究方法论临床研究方法论
医疗服务研究医疗服务研究
监管科学是一种监管科学.

背景情况:

临床研究在全球范围内取得了进展,葡萄牙在监管调整和数字工具方面取得了进展.
葡萄牙持续面临的挑战包括资金有限,患者招募缓慢,监管延迟等.
优化临床研究实践对于在葡萄牙推进医疗保健至关重要.

研究的目的:

确定葡萄牙临床研究实践需要改进的关键领域.
为了实现全国专家在优化该国临床研究方面达成共识.

主要方法:

在2023-2024年期间进行的修改后的三轮在线Delphi研究.
一个科学委员会在五个主题上制定了45份声明:研究时间,综合研究中心,试验实施,机构当局和患者招聘.
五十一名专家在五分利克特级别上对陈述进行了评分,共识由协议门定义 (第1轮≥90% ,第2轮≥85%).

主要成果:

在第一轮的45个初步陈述中,32个初步陈述 (71.1%) 达成了共识.
在第二轮包括四个新的声明之后,在49个最终声明中的45个 (91.8%) 中达成共识.
在组织综合研究中心和实施临床试验的条件方面,观察到最大的协议. 患者招募和机构支持表明需要进一步对话的领域.

结论:

该研究为卫生组织,监管机构和利益相关者提供了可操作的见解,以加强葡萄牙的临床研究.
解决发现的障碍和利用机会可以提高葡萄牙在国际临床研究中的地位.
需要进一步的对话和创新解决方案来招募和转诊患者,以及机构当局促进临床研究.

关键词:

临床研究是临床研究.临床试验临床试验临床试验临床试验临床试验德尔菲的方法方法德尔菲方法葡萄牙葡萄牙研究框架研究研究框架.

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