在多个临床试验中共同注册的决策网格
Nursing research
|December 16, 2024
概括
决策网格 (GRID) 提供了一种系统的方法来评估临床试验的共同注册,确保科学完整性. 该工具有助于研究人员确定试验兼容性,促进对多项研究的受试者招募的知情决策.
科学领域:
- 临床研究方法论临床研究方法论
- 试验设计和进行.
背景情况:
- 在多个临床试验中共同注册受试者是可取的,但需要仔细考虑.
- 损害科学完整性是一个必须减轻的风险.
研究的目的:
- 开发一个决策网格 (GRID),以评估临床试验的兼容性.
- 区分兼容 (允许联合注册) 和竞争 (禁止联合注册) 的试验.
主要方法:
- 该GRID在四个领域评估了21个要素:科学完整性,数据解释,可行性/负担以及其他考虑因素.
- 主要调查人员独立地使用共享的协议完成GRID,然后调和差异.
主要成果:
- 该GRID被应用于儿科重症监护试验 (RESTORE和PROSpect).
- 在RESTORE中,5项试验中,有1项被批准共同注册;4项是竞争性.
- 在PROSpect中,26项试验中有20项被批准共同注册;6项是竞争性.
结论:
- 该GRID提供了一个结构化的过程,用于评估共同招生的影响.
- 它有助于调查人员对多个试验受试者入学做出系统决策.
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