在先发性阿尔茨海默病临床试验中的生物标志物披露协议
Annalise Rahman-Filipiak1,2, Corey Bolton3,4, Joshua D Grill5
1Research Program on Cognition & Neuromodulation Based Interventions, University of Michigan, Ann Arbor, Michigan, USA.
概括
在阿尔茨海默病 (AD) 试验中披露生物标志物是罕见的. 报告生物标志物结果给参与者的标准化方法是必要的,以确保伦理试验的进行和改善阿尔茨海默病研究的结果.
科学领域:
- 神经科学是一个神经科学.
- 临床试验 临床试验
- 生物标志物研究 生物标志物研究
背景情况:
- 阿尔茨海默病 (AD) 的生物标志物使得早期的治疗测试和改善的参与者选择.
- 对参与者进行生物标志物结果的标准化披露至关重要,但在临床试验中并不一致实施.
研究的目的:
- 评估在预发性阿尔茨海默病 (AD) 临床试验中生物标志物披露报告的频率和深度.
- 发现生物标志物测试结果向研究参与者报告的漏洞.
主要方法:
- 在过去10年中发表的前性AD试验的文献综述.
- 生物标志物披露报告频率和描述深度的量化.
主要成果:
- 在30项审查的试验中,只有一项提到生物标志物披露.
- 没有任何试验提供了用于披露的方法的详细信息.
结论:
- 在阿尔茨海默病 (AD) 试验中,关于生物标志物披露的信息缺口很大.
- 一致的整合和披露报告是道德行为和试验成功所必需的.
- 建议制定最佳实践指南和披露培训.
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