提高急性中风试验的入学率:当前状态和共识建议
Joseph P Broderick1, Gisele Sampaio Silva2, Magdy Selim3
1Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.A., E.A.M.).
Stroke
|September 11, 2023
概括
改善急性中风试验入学率对于推进中风护理至关重要. 关键策略包括简化紧急同意和将试验流程整合到标准的临床工作流程中,以加快研究和改善患者的结果.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 脑卒中研究 脑卒中研究
背景情况:
- 急性中风试验对于开发新疗法至关重要.
- 参与者招生是中风研究中的一个重大瓶.
- 卒中治疗学术行业圆桌会议 (STAIR) 召集专家,以解决招生挑战.
研究的目的:
- 确定影响急性中风试验入学的关键问题.
- 讨论和提出可行的解决方案,以改善参与者招聘.
- 提高中风试验参与者池的效率和代表性.
主要方法:
- 一个研讨会,涉及中风医生,研究人员,监管机构 (NINDS,FDA) 和行业代表.
- 讨论和识别招生障碍.
- 开发潜在的行动项目,以应对已识别的挑战.
主要成果:
- 确定了影响注册的关键领域:紧急同意,资格标准,人员配置,现场激活和试验设计.
- 强调需要更广泛地理解和实施紧急同意的必要性.
- 强调将学习程序整合到标准工作流程中,并利用远程医疗来集中招生.
结论:
- 参与者招生是推动急性中风治疗的速度限制步骤.
- 改善紧急许可程序和工作流程集成是必不可少的.
- 简化试验流程和更广泛的参与最终将改善中风的结果.
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