IDERHA: Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance

IDERHA：异构数据和证据的整合以实现监管和 HTA 接受

• 批准号: 10079453
• 金额: $ 110.31万
• 依托单位: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
• 依托单位国家: 英国
• 项目类别: EU-Funded
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10079453
• 关键词: IDERHA; Integration; heterogeneous; Data; Evidence

IDERHA will address the key obstacles to achieving appropriate access, sharing, use and reuse of lung cancer data, and thus enable enhanced regulatory and HTA decision-making recommendations for integrated health research, with the aim to improve care and better meet the needs of patients and health care professionals. The IDERHA open platform for multi-modal health data will enhance innovation in EU health care systems and is directly scalable by means of connecting additional systems, data sources and additional services and tools. It will extend and elaborate standards in semantic interpretation, data quality, ethics and transferability to ensure the harmonisation of heterogeneous data sources and wider health data reuse. Use cases positioned along the lung cancer patient pathway will be implemented using retrospective data and in a remote patient care context. These practical implementations will demonstrate the added value of multi-modal data aggregation and analysis with impacts expected on public health, patient burden, health outcomes and cost. We will perform AI/ML based lung-cancer risk profiling using patient`s EHRs, and improved CT image- based AI/ML to provide risk prediction of potential lung cancer patients, and explore the possibilility of personal prognosis of disease progression. Using patient monitoring and engagement, including digital biomarker, PROMs, and connected devices, the IDERHA platform will enable remote patient monitoring, and provide data for joint patient-health professional decision making. Along with health care stakeholders, IDERHA will develop consensus policy recommendations for appropriate data sharing to enable multi-stakeholder research. Informed by Patient Advisory Groups, we will address critical obstacles and issues to heterogeneous health data primary and secondary use. Regulatory and HTA agencies will be engaged to create criteria for assessing the acceptability of heterogeneous health research results in regulatory and HTA decision-making.

IDERHA将解决实现肺癌数据的适当访问，共享，使用和再利用的关键障碍，从而为综合健康研究提供增强的监管和HTA决策建议，旨在改善护理并更好地满足患者和医疗保健专业人员的需求。IDERHA多模式健康数据开放平台将加强欧盟医疗保健系统的创新，并通过连接其他系统，数据源和其他服务和工具直接扩展。它将扩展和制定语义解释、数据质量、道德和可转移性方面的标准，以确保异构数据源的协调和更广泛的卫生数据再利用。沿着肺癌患者路径定位的用例将使用回顾性数据并在远程患者护理环境中实施。这些实际实施将展示多模式数据汇总和分析的附加值，以及对公共卫生、患者负担、健康结果和成本的预期影响。我们将使用患者的EHR进行基于AI/ML的肺癌风险分析，并改进基于CT图像的AI/ML，以提供潜在肺癌患者的风险预测，并探索疾病进展的个人预后的可能性。通过使用患者监测和参与，包括数字生物标志物、PROM和连接设备，IDERHA平台将实现远程患者监测，并为患者-健康专业人员联合决策提供数据。沿着卫生保健利益相关者，IDERHA将制定共识政策建议，以适当的数据共享，使多利益相关者的研究。在患者咨询小组的指导下，我们将解决异构健康数据主要和次要使用的关键障碍和问题。监管和卫生技术评估机构将参与制定标准，以评估监管和卫生技术评估决策中异质性卫生研究结果的可接受性。