在帕金森病中研究疾病修饰疗法的试验中研究试验设计变异性:一个范围审查协议
Marie-Louise Zeissler1,2, Timothy Boey3, Danny Chapman2
1Newcastle University, Newcastle upon Tyne, UK marie-louise.zeissler@plymouth.ac.uk.
BMJ open
|December 9, 2023
概括
本范围审查检查了帕金森病 (PD) 临床试验设计的疾病修饰干预措施. 它旨在确定这种神经疾病的试验策略的趋势和变化.
科学领域:
- 神经学 神经学
- 临床试验设计 临床试验设计
- 神经退行性疾病 神经退行性疾病
背景情况:
- 帕金森病 (PD) 对开发疾病修饰治疗提出了重大挑战,原因是人口异质性和结果测量限制.
- 目前的研究缺乏关于针对PD进展的干预措施的最佳临床试验设计的共识.
- 确定有效的PD疾病修饰疗法仍然是一个关键的未满足的需求.
研究的目的:
- 对帕金森病 (PD) 试验设计变异性的当代更新进行范围审查协议.
- 分析用于PD疾病修饰干预的各种试验设计.
- 确定PD临床试验设计中的新兴趋势和共识.
主要方法:
- 使用人口,干预,比较,结果和研究设计 (PICOS) 框架.
- 系统地搜索MEDLINE,科学网,Cochrane和临床试验.gov的相关研究和注册表条目.
- 数据提取和对研究信息,资格标准,结果措施和试验设计的描述性分析,遵守PRISMA范围审查指南.
主要成果:
- 本节将介绍范围审查的调查结果.
- 该审查将详细介绍PD疾病修饰干预的试验设计选择中的变化和新兴趋势.
结论:
- 该研究将全面概述帕金森病 (PD) 临床试验设计当前的做法.
- 这些发现将为未来的研究和PD疾病修饰疗法的开发提供信息.
- 这项工作旨在为PD临床试验的标准化和效率做出贡献.
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