在试验中使用和报告代用终点的定义,可接受性,限制和指导:范围审查
Anthony Muchai Manyara1, Philippa Davies2, Derek Stewart3
1MRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Journal of clinical epidemiology
|June 28, 2023
概括
本研究综合了临床试验中代理终点的文献,开发了17个报告项目,以改善试验设计和透明度. 这些项目涵盖了定义,理由,方法,结果和参与者信息,以更好地利用替代终点.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 证据综合 证据综合
背景情况:
- 替代终点在临床试验中至关重要,但需要明确的定义,理由和报告标准.
- 现有的关于代用终点的文献缺乏用于试验报告的全面综合.
- 确保代用终点的有效性和适当使用对于可靠的试验结果至关重要.
研究的目的:
- 综合当前关于代用终点的文献.
- 制定报告指南项目,用于在临床试验中设计和报告代用终点.
- 为开发试验报告指南的扩展提供信息,例如SPIRIT和CONSORT.
主要方法:
- 进行了对文献和灰色文献来源的系统文献搜索.
- 数据被主题分析成以下类别:定义,可接受性,限制和指导.
- 结果被综合成17个潜在的试验报告项目.
主要成果:
- 审查中包括了90份文件,提供了关于替代终点的定义,可接受性,限制和指导的数据.
- 开发了17个报告项目,涵盖了关于代孕使用的明确陈述,理由,方法考虑,结果报告,讨论,证实性研究和参与者信息.
- 涉及的重点领域包括由代孕有效性和数据共享计划所依据的样本大小计算.
结论:
- 综合报告项目为改善在临床试验中使用代用终点提供了一个框架.
- 这些项目将有助于制定标准化报告准则 (SPIRIT-SURROGATE和CONSORT-SURROGATE).
- 改进的报告将提高依赖替代终点的试验结果的透明度,有效性和解释.
关键词:
康索尔特 - 代用人设计设计设计设计设计设计.协议 协议 协议 协议随机对照试验是随机对照试验.报告指南 报告指南灵魂 - 替代品的替代品范围审查 范围审查替代终点是一个替代终点.验证 验证 验证 验证更多相关视频
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