参与行业资助的临床试验的患者负担的趋势
Abigail Dirks1, Emily Botto2, Zachary Smith2
1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. Abigail.dirks@tufts.edu.
自2011年以来,患者参与临床试验的负担稳步增加. 协议设计必须纳入患者的需求,以优化试验参与和减少负担.
科学领域:
- 临床试验操作临床试验操作
- 制药研发领域的研究和开发.
- 以患者为中心的药物开发.
背景情况:
- 越来越多的制药行业对以患者为中心的协议设计感兴趣.
- 与14家制药公司合作,使用经过验证的方法来评估患者参与负担.
- 2011-2022年患者参与负担数据的汇总.
研究的目的:
- 分析临床试验中患者参与负担的趋势.
- 确定有助于增加患者负担的关键程序.
- 通过负载评估来告知协议设计优化.
主要方法:
- 对156个II期和III期临床试验方案的分析.
- 数据汇总和对患者参与负担的趋势分析.
- 评估有助于访问时间和总体负担的程序.
主要成果:
- 从2011年到2022年,患者参与总体负担的稳步增加.
- 患者问卷,实验室工作和例行程序是造成负担的主要原因.
- 访问时间的增加是由于程序的数量增加,包括探索性终点的程序.
结论:
- 患者参与临床试验的负担正在增加.
- 协议设计需要解决患者负担,特别是关于访问频率和程序.
- 评估患者负担对于优化临床试验方案和加强患者参与至关重要.
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