临床试验中的药物坚持:错过了树木的森林
Sanskriti Shukla1, Rohan Tripathi2, Saibal Das3,4
1Translational Health Science and Technology Institute, Faridabad, India.
The International journal of pharmacy practice
|October 16, 2025
概括
在临床试验中改善药物坚持测量是至关重要的. 新的工具和策略可以提高试验有效性,降低成本,并确保结果反映真实世界的患者结果.
科学领域:
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
- 医疗保健服务研究 医疗服务研究
背景情况:
- 药物坚持对于临床试验的有效性至关重要,但往往被衡量得很差.
- 不遵守可以引入效果和安全性数据的偏见,膨胀试验成本,并妥协监管决策.
研究的目的:
- 审查在临床试验中不遵守的影响.
- 评价传统的自我报告方法与较新的依从度测量工具.
- 突出在研究环境中改善药物坚持的策略.
主要方法:
- 对临床试验中药物坚持测量的现有文献的审查.
- 讨论自我报告方法的局限性.
- 探索先进技术,如电子监测,血清药物度和可摄入传感器等.
- 检查行为干预,数字工具和试验设计修改.
主要成果:
- 传统的自我报告方法来衡量坚持是不够的.
- 电子监测和血清药物度等新型工具提供了更客观的测量方法.
- 行为干预和优化的试验设计显示出增强坚持的潜力.
- 标准化报告框架 (例如,EMERGE) 需要进一步验证.
结论:
- 需要全面的策略来改善临床试验中的药物坚持测量和管理.
- 考虑到患者群体和研究环境的定制方法至关重要.
- 未来的研究应该专注于可扩展的实时跟踪,预测建模和协调的定义,以便更好地进行比较和决策.
- 有效地解决依从性问题将改善临床试验的一致性和研究结果对临床实践的概括性.
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