加强多发性硬化症患者在临床试验设计中的参与
Emma Gray1, Anneesa Amjad1, Jenny Robertson1
1Department of Research, MS Society UK, London, UK.
概括
患者和公众参与 (PPI) 对于设计多发性硬化症 (MS) 有效的临床试验至关重要. 有意义的PPI提高了研究质量,相关性和患者社区影响.
科学领域:
- 临床试验 临床试验
- 患者和公众参与 (PPI)
- 多发性硬化症 (MS) 研究研究
背景情况:
- 患者和公众参与 (PPI) 对于复杂的临床试验设计在慢性疾病如多发性硬化症 (MS) 中至关重要.
- 在MS临床试验的设计和交付中,PPI经常被忽视.
研究的目的:
- 在过去五年中,审查PPI在MS临床试验设计和进行中的现状.
- 介绍PPI的案例研究,以开发一个平台临床试验的进展性MS.
主要方法:
- 在MS临床试验中使用快速审查方法来评估PPI.
- 描述了OCTOPUS试验的PPI开发过程的一个案例研究.
主要成果:
- 只有八个独特的临床试验在其文章或协议中报告了PPI.
- 大多数PPI试验是由鼓励或强制包括PPI的组织资助的.
- 奥克托普斯试验是与MS受影响的人共同设计的典范,导致了可访问和包容的设计.
结论:
- 积极和有意义的PPI显著提高了临床试验的质量,相关性和对患者社区的影响.
- 提供了建议,以加强PPI在未来的MS临床试验.
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