Real-world evidence for decisions in diabetes

糖尿病决策的真实证据

• 批准号: 10066570
• 金额: $ 21.96万
• 依托单位: UNIVERSITY OF WARWICK
• 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=10066570
• 关键词: Real; world; evidence; decisions; diabetes

Randomised controlled trials are the cornerstone of evidence-based medicine. However, the digitisation of real-world data (RWD) including data from devices, wearables, and electronic health records in large national registries provides opportunities to demonstrate efficacy and safety of innovative technologiesincluding drugs, devices, diagnostics, and digital health. These data are particularly relevant to long-term conditions such as diabetes mellitus, where drugs, lifestyle interventions, and digital technologies often work together. To better utilise RWD in diabetes for regulatory decision making, a development of standards, guidance, and an assessment of the efficacy to effectiveness gap is needed. REDDIE (Real-World Evidence for Decisions in Diabetes) aims to explore how RWD can complement RCTs to improve efficacy, safety, and value for money of technologies to prevent and treat diabetes. The overall aim of REDDIE is to support the use of RWD in diabetes and health-related research, which will maximise Europe’s scientific expertise and know-how to benefit people with diabetes, resulting in safer, more efficient, and cost-effective interventions. We thus aim to engage with stakeholders such as regulatory and HTA authorities and co-develop evidentiary standards for the collection, assessment, and acceptability of RWD. We will then develop and validate state-of-the art modelling techniques using synthetic data derived from large national registries to better assess outcomes of interventions using RWD. We will use data from four large national registries to elucidate the gap between outcomes in RCTs and RWD studies, and understand the factors that affect this gap. Finally, we will test the ability of machine learning to facilitate the better use of RWD. REDDIE will generate standards for RWD use for the evaluation of medicines and other interventions by regulatory authorities and HTA bodies

随机对照试验是循证医学的基石。但是，实际数据（RWD）的数字化包括大型国家注册表中的设备，可穿戴设备和电子健康记录的数据，为展示了包括药物，设备，诊断和数字健康在内的创新技术的效率和安全的机会。这些数据与长期疾病特别相关，例如糖尿病，药物，生活方式干预和数字技术经常共同起作用。为了更好地利用RWD在糖尿病中进行监管决策，需要对标准，指导的发展以及对有效性差距的有效性进行评估。 Reddie（现实世界中的糖尿病决策证据）旨在探索RWD如何完成RCT，以提高技术资金的效率，安全性和价值，以预防和治疗糖尿病。 Reddie的总体目的是支持RWD在糖尿病和与健康相关的研究中的使用，这将最大程度地吸收欧洲的科学专业知识和专业知识，以使糖尿病患者受益，从而导致更安全，更有效，更具成本效益的干预措施。因此，我们的目标是与RWD的收集，评估和可接受性等利益相关者（例如监管和HTA当局以及共同开发的证据标准）互动。然后，我们将使用从大型国家注册表中得出的合成数据来开发和验证最先进的建模技术，以更好地评估使用RWD的干预措施的结果。我们将使用来自四个大型国家注册表的数据来阐明RCT和RWD研究结果之间的差距，并了解影响这一差距的因素。最后，我们将测试机器学习能够更好地利用RWD的能力。 Reddie将生成用于评估药品和其他干预措施的RWD标准，监管机构和HTA机构