患者偏好科学的下一步是什么? 互操作性,标准化和可转移性
Kevin Marsh1, Juan Marcos Gonzalez Sepulveda2, Conny Berlin3
1Evidera, London, UK. kevin.marsh@thermofisher.com.
The patient
|January 28, 2025
概括
在药物开发中整合患者偏好信息 (PPI) 面临障碍. 使PPI FAIR (可查找,可访问,可互操作,可重复使用) 需要科学进步和数据标准,以获得更好的以患者为中心的疗法.
科学领域:
- 药物经济学和健康研究成果研究成果
- 患者报告的结果
- 药物开发科学 药物开发科学
背景情况:
- 将患者偏好信息 (PPI) 纳入药物开发过程对于将疗法与患者需求和价值观相协调至关重要.
- 显著的障碍阻碍了PPI的使用,包括决策者缺乏清晰度,信任不足以及资源限制 (时间,预算,专业知识).
- 通过坚持公平原则来提高PPI的价值:可查找,可访问,可互操作和可重复使用.
研究的目的:
- 提出一个研究议程,以制定FAIR PPI.
- 确定PPI科学中必要的进展,以克服当前的局限性.
- 探索提高PPI效率和可信度的策略.
主要方法:
- 审查了数据库,疾病建模,福利转移和数据标准方面的现有举措.
- 分析了决策者清晰度,信任和资源分配的障碍.
- 检查了FAIR数据原则在提高PPI价值方面的潜力.
主要成果:
- 开发FAIR PPI需要在该领域取得科学进步.
- 建议建立一个专门的财团,类似于CDISC或OMOP,用于创建PPI数据标准.
- 需要进一步的研究来理解和解释患者偏好的变化.
结论:
- 推动PPI科学从经验观测到理论框架是必不可少的.
- 制定强大的PPI数据标准和了解偏好变化将提高效率和信任.
- 实施FAIR原则和一个协作联盟可以显著提高PPI在药物开发中的作用.
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