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在临床试验注册表中报告总结结果:世卫组织的最新指南
An-Wen Chan1, Ghassan Karam2, Justin Pymento1
1Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
在注册表中公开报告临床试验结果至关重要,但不常见. 世界卫生组织 (WHO) 的新指南旨在到2025年改善所有试验的总结结果报告.
科学领域:
- 临床试验 临床试验
- 卫生政策 卫生政策
- 基于证据的医学基于证据的医学.
背景情况:
- 公共注册和对临床试验的结果报告对于完整的证据基础至关重要.
- 尽管有要求,但在注册表中报告试验结果仍然很少,导致资源浪费和数据不完整.
研究的目的:
- 讨论在试验注册表中报告总结结果的理由.
- 审查当前的注册政策,并引入世界卫生组织 (WHO) 关于结果报告的新指南.
- 定义理解和解释试验总结结果的基本组成部分.
主要方法:
- 审查当前的临床试验注册政策.
- 通过多方利益相关者商,制定新的世卫组织指导方针.
- 对汇总结果报告的八个最低数据项的定义.
主要成果:
- 世卫组织已经制定了新的指导方针,用于在试验登记册中报告总结结果.
- 该指南规定了对于理解和解释试验结果的八个基本项目.
- 实施需要注册,调查人员,赞助商的遵守,以及各种卫生组织的认可.
结论:
- 实施世卫组织指南可以提高临床试验对科学知识和患者护理的贡献.
- 广泛的遵守和认可是提高试验结果可用性和有用性的关键.
- 该倡议旨在消除证据缺陷,减少研究浪费.
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