为地质科学试验选择适当的临床试验终点:走向共识的道路
Stephen Kritchevsky1, Ezequiel Zamora2, Shalender Bhasin3
1Wake Forest School of Medicine.
Research square
|February 24, 2025
概括
专家建议,临床试验终点应评估多个健康维度,包括疾病,功能和患者目标,而不仅仅是生物标志物. 这将指导未来的地质科学试验设计.
科学领域:
- 老年学和老年医学是老年学和老年医学.
- 临床试验设计 临床试验设计
- 翻译研究是翻译研究.
背景情况:
- 设计有效的临床试验,需要对适当的结果措施达成共识.
- 当前的终点可能无法充分捕捉衰老和与年龄相关的疾病的多面性质.
研究的目的:
- 为了在针对预防或治疗多种与年龄有关的疾病的试验中对临床终点选择达成专家共识.
- 引导未来地质科学研究的发展.
主要方法:
- 一个经过修改的Delphi过程,涉及28名临床试验,老年病学和研究翻译专家.
- 利用焦点小组开发主题,然后进行参与者调查以建立共识.
主要成果:
- 达成共识,结果措施必须包括多个健康维度:与年龄相关的疾病,功能和患者报告的结果,反映参与者的目标.
- 终点应根据特定的人口特征量身定制.
- 基于血液的生物标志物不太可能被接受为主要疗效终点.
- 可信的复合终点组件包括死亡率,运动功能和多种与年龄有关的疾病的发病.
结论:
- 建立了关于临床试验终点的关键组件的专家协议.
- 研究结果为设计未来专注于衰老和多种并发症的试验提供了关键指导.
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