Use of Registries, Claims and Health System Data to Enhance the Evaluation of Cardiovascular Therapies in Clinical Trials

使用注册、索赔和卫生系统数据来加强临床试验中心血管治疗的评估

• 批准号: 9897550
• 负责人: Robert Yeh
• 金额: $ 79.1万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9897550
• 关键词: Accounting; American; Area; Cardiac; Cardiology; Cardiovascular system; Caring; Characteristics; Clinical; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Collaborations; Common Data Element; Communities; Complement; Coronary; Data; Data Set; Data Sources; Databases; Devices; Effectiveness; Enrollment; Evaluation; Future; Goals; Gold; Health; Health system; Heart Valve Diseases; Hospitalization; Hospitals; Infrastructure; Insurance Carriers; Intervention; Israel; Link; Measures; Medical; Medical center; Methods; Multi-Institutional Clinical Trial; Outcome; Outcomes Research; Patient Care; Patient Representative; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Population; Probability; Procedures; Public Health; Public Health Schools; Randomized; Registries; Research; Research Design; Research Institute; Resources; Risk Factors; Risk stratification; Safety; Source; Stents; Subgroup; Testing; Time; Validation; Weight; aortic valve replacement; base; cardiovascular health; clinical care; clinical practice; college; comparative; cost; data registry; frailty; health care quality; high dimensionality; improved; individual patient; insight; novel; patient subsets; personalized care; population based; post-market; programs; routine care; treatment effect; treatment response; treatment strategy; trial comparing

PROJECT SUMMARY/ABSTRACT The timely and efficient evaluation of new medical treatment strategies, therapies and devices is critical to improving public health. Ubiquitous data collected in the routine care of patients, including registries, health systems and payers, remain underutilized sources of information that could be used to support clinical trial evaluations of novel medical interventions, but require validation. Through a collaboration involving the Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center, Harvard Clinical Research Institute, the Harvard T.H. Chan School of Public Health, the American College of Cardiology (ACC), Premier, Inc., Symphony Health Solutions and Medtronic, we will combine data from two landmark clinical trial programs - the Dual Antiplatelet Therapy (DAPT) Study and the US CoreValve Trials - with comprehensive national data from registries, health systems and payers, to test several hypotheses central to the future evaluation of cardiovascular therapies. In Aim 1, we will test the hypothesis that trial outcomes derived from linked registry, hospital, and claims data will be equivalent to outcomes obtained in clinical trials, suggesting that these alternative data sources can, in some cases, replace traditional clinical trial data. In Aim 2, we will test the hypothesis that information collected through registries, hospitals, and claims that was not collected in the original clinical trial, such as prior non-cardiac hospitalizations and markers of frailty, can augment trial data, through improved risk stratification and identification of heterogeneous treatment effects. In Aim 3, we will leverage the linkage of trials with population-based datasets to enable the creation of novel and broadly applicable metrics to assess overall trial generalizability and applicability to understudied subgroups. The linkage of these diverse resources will create an important opportunity to formally evaluate the strengths and limitations of using non-clinical trial data sources to support and improve clinical trial assessments of medical therapies. The information learned has the potential to greatly inform the future conduct of pragmatic and naturalistic clinical trials, while offering novel insights into the efficacy and safety of therapies to treat coronary and valvular heart disease.

项目概要/摘要 及时有效地评估新的医疗策略、疗法和设备对于 改善公共卫生。在患者的日常护理中收集的无处不在的数据，包括登记、健康 系统和付款人，可用于支持临床试验的信息来源仍未得到充分利用 对新型医疗干预措施的评估，但需要验证。通过与史密斯的合作 贝斯以色列女执事医疗中心结果研究中心、哈佛临床研究所、 哈佛大学 T.H.陈公共卫生学院、美国心脏病学院 (ACC)、Premier, Inc.、 Symphony Health Solutions 和美敦力 (Medtronic)，我们将结合两个具有里程碑意义的临床试验项目的数据 - 双联抗血小板治疗 (DAPT) 研究和美国 CoreValve 试验 - 具有全面的国家数据 来自登记处、卫生系统和付款人的信息，以测试对未来评估至关重要的几个假设 心血管治疗。在目标 1 中，我们将检验以下假设：试验结果源自关联注册中心， 医院和索赔数据将相当于临床试验中获得的结果，表明这些 在某些情况下，替代数据源可以取代传统的临床试验数据。在目标 2 中，我们将测试 假设通过登记处、医院和索赔收集的信息未在登记处收集 原始临床试验，例如先前的非心脏病住院治疗和虚弱标志，可以增强试验数据， 通过改进风险分层和异质治疗效果的识别。在目标 3 中，我们将 利用试验与基于人群的数据集的联系来创建新颖且广泛的 适用的指标来评估总体试验的普遍性和对未充分研究的亚组的适用性。这 这些不同资源的联系将为正式评估优势和优势创造重要机会。 使用非临床试验数据源支持和改进医学临床试验评估的局限性 疗法。所学到的信息有可能为未来的务实和 自然临床试验，同时为治疗冠心病的疗法的有效性和安全性提供新的见解 和瓣膜性心脏病。