Health Care Systems Research Collaboratory - Coordinating Center

卫生保健系统研究合作实验室 - 协调中心

基本信息

批准号：
8721108
负责人：
ROBERT M CALIFF
金额：
$ 23.09万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-30 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8721108
关键词：
Adopted Back Cessation of life Clinical Research Clinical Trials Collaborations Commit Communication Conduct Clinical Trials Data Data Sources Development Documentation Education Electronic Health Record Funding Generations Goals Guidelines Health Health Planning Health Sciences Health system Healthcare Healthcare Systems Institute of Medicine (U.S.)Institutes Integrated Delivery Systems Learning Link Literature Medical Medical Technology Methods Multicenter Studies Observational Study Patient Outcomes Assessments Patients Policies Private Practice Procedures Publications Randomized Clinical Trials Registries Research Research Infrastructure Research Institute Research Personnel Site Speed System Testing United States National Institutes of Health Universities Work base care delivery clinical care collaboratory cost cost effectiveness design disability expectation experience feeding health care delivery improved medical schools randomized trial research study systems research

项目摘要

We propose to create a Collaboratory Coordinating Center (Collaboratory CC) to work with the NIH to produce, document, and disseminate standards, and to create durable infrastructure that facilitates multicenter studies and reuse of data. The Collaboratory CC will be based at Duke University, with participation by the Harvard Pilgrim Health Care Institute at Harvard Medical School, the Group Health Research Institute, Johns Hopkins University and the Center for Medical Technology Policy. Our investigators have established multi-center research collaborations using electronic health records (EHRs), convened stakeholders to transform clinical trials, developed new regulatory approaches, and pioneered the use of patient-reported outcomes (PROs) in clinical research. This team has extensive experience in conducting both conventional and cluster randomized clinical trials, quasi-experimental studies, and observational studies across the spectrum of health systems, including integrated delivery systems and health plans, academic health and science systems, and private practices. The critical importance of this effort is reinforced by recent literature demonstrating that the vast majority of medical decisions are not supported by high quality evidence and that the clinical trials system is focused on small trials without sufficient power to fully inform practice or policy. In the face of this evidence gap the Institute of Medicine has called for a transformation of clinical trials rather than incremental improvements. This transformation should deal with the current fundamental separation of the conduct of clinical trials from the delivery of clinical care by involving practitioners and their health systems in th design and interpretation of trials, providing the broad education needed to enhance the value of practitioner participation and using the data collected as part of healthcare delivery as the core data source for the full spectrum of clinical research, from registries to observational studies an randomized trials. We believe that we are at a "tipping point", that if propelled by a powerful Collaboratory effort, will enjoin multiple public and private entities towards the common goal of a Learning Health System. At the end of the five-year funding period, new policies, procedures, governance capabilities, and a substantial infrastructure will enable larger, simpler, less expensive and more relevant clinical trials that will be an integral component of the healthcare system.

我们建议创建一个合作实验室协调中心（Collaboratory CC），与 NIH 合作制定、记录和传播标准，并创建持久的基础设施，促进多中心研究和数据重用。该合作CC将设在杜克大学，由哈佛医学院的哈佛朝圣者医疗保健研究所、团体健康研究所、约翰·霍普金斯大学和医疗技术政策中心参与。我们的研究人员利用电子健康记录 (EHR) 建立了多中心研究合作，召集利益相关者转变临床试验，开发新的监管方法，并率先在临床研究中使用患者报告结果 (PRO)。该团队在整个卫生系统范围内进行传统和整群随机临床试验、准实验研究和观察研究方面拥有丰富的经验，包括综合交付系统和健康计划、学术健康和科学系统以及私人诊所。最近的文献证明，绝大多数医疗决策没有高质量证据的支持，并且临床试验系统专注于小型试验，没有足够的权力来充分告知实践或政策，这进一步证明了这项努力的至关重要性。面对这一证据差距，医学研究所呼吁临床试验进行转型，而不是渐进式改进。这种转变应通过让从业者及其卫生系统参与试验的设计和解释，提供提高从业者参与和使用的价值所需的广泛教育，解决目前临床试验的实施与临床护理的提供的根本分离。作为医疗保健服务的一部分收集的数据，作为从登记到观察性研究和随机试验的全方位临床研究的核心数据源。我们相信，我们正处于一个“临界点”，如果在强大的合作努力的推动下，将促使多个公共和私人实体实现共同目标：学习健康系统。五年资助期结束时，新的政策、程序、治理能力和强大的基础设施将使规模更大、更简单、成本更低、相关性更强的临床试验成为可能，成为医疗保健系统不可或缺的组成部分。