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关于公共卫生实践中临床试验的公平报告

E Andrew Balas¹, Bussi S Bussi², Noha Asem³

¹Biomedical Research Innovation Laboratory, Augusta University, Augusta, GA, USA.

Proceedings of the European Academy of Sciences & Arts

|June 7, 2024

概括

临床试验报告往往缺乏必要的实施细节,阻碍了公共卫生的自动化. 提出了一个新的报告结构,即PROTON表,以提高数据的可访问性和可用性.

科学领域:

公共卫生公共卫生
临床试验临床试验
数据管理数据管理

背景情况:

由于越来越多的研究,临床试验自动化是必要的.
当前的临床试验报告往往缺乏对公共卫生实施至关重要的信息.

研究的目的:

评估和提高临床试验报告的准备程度,以实现自动检索和公共卫生应用.
识别使试验结果无法使用的设计元素.

主要方法:

在 Medline 搜索与非洲相关的艾滋病毒/艾滋病管理试验.
使用FAIR数据原则 (可查找,可访问,可互操作,可重复使用) 评估了96份试验报告.
分类结果和实施要点,识别缺少的信息.

主要成果:

基本的实施细节,如人员,材料和培训方法经常缺失.
65%的研究报告了健康结果,但很少有人显示出积极的影响.
确定了设计缺陷,使许多试验结果无法使用.

结论:

临床试验报告往往缺乏实际实施细节,并呈现出无法理解的结果.
开发了一种新的报告结构,即以实践和检索为导向的试验概要与数值结果 (PROTON) 表.
公平数据原则要求在所有临床试验报告中提供一致,实用,以影响为导向的表格.

关键词:

临床试验是指临床试验中的临床试验.公共卫生实践公共卫生实践

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