Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trial Network

一体化、个体化、智能处方（I3P）临床试验网络

基本信息

批准号：
10459256
负责人：
Kerri Cavanaugh
金额：
$ 126.59万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-19 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10459256
关键词：
Academic Medical Centers Address Adoption Biological Assay Caring Clinical Clinical Trials Clinical Trials Network Collaborations Computerized Medical Record Conduct Clinical Trials Decision Making Development Diagnosis Diagnostic Disease Dose Ecosystem Electronic Health Record Electronic Medical Records and Genomics Network Funding General Hospitals Genetic Genetic Risk Genomic medicine Genomics Genotype Health Health Personnel Health system Historically Black Colleges and Universities Hospitals Individual Infrastructure Institution Integrated Health Care Systems Intelligence Intervention Laboratories Mendelian disorder Methods Midwestern United States Outcome Participant Patients Pharmaceutical Preparations Pharmacogenomics Phenotype Population Population Heterogeneity Pragmatic clinical trial Preventive care Primary Health Care Process Provider Randomized Recommendation Research Resources Risk Signs and Symptoms Site Technology Testing Therapeutic Time Translations Uncertainty Underserved Population United States Health Resources and Services Administration United States National Institutes of Health Use Effectiveness Variant Work arm base body system clinical care clinical decision support clinical practice clinical research site cohort cost effectiveness disorder risk economic value evidence base genetic information genetic testing genomic data genomic variation high risk knowledgebase medical schools medically underserved novel patient population pharmacogenetic testing pragmatic trial present value programs recruit response sociodemographics tertiary care therapy outcome tool underserved rural area urban setting

项目摘要

Project Summary Using genomic variation to tailor therapeutic, preventative, and diagnostic decision-making is a potentially transformative approach to clinical care. However, uncertainty about clinical impact and economic value presents a critical barrier to broad adoption. The Integrated, Individualized, Intelligent Prescribing (I3P) Clinical Trials Network includes three clinically and sociodemographically diverse health systems to IGNITE 2: Metro General Hospital at Meharry Medical College, Sanford Health and Vanderbilt University Medical Center (VUMC). The Network will develop infrastructure to quickly recruit large, diverse patient populations, return results at the time of clinical indication, and provide health care providers with understandable, implementable guidance during the course of the trial. The first aim will develop and implement infrastructure to efficiently conduct pragmatic clinical trials involving Genomic Medicine across the diverse settings within I3P. The second aim proposes a randomized, pragmatic clinical trial of multiplexed pharmacogenomics testing across the IGNITE 2 Network to establish the clinical utility of panel testing. And finally, I3P will develop and implement an IGNITE 2 Network-wide capability to calculate Phenotype Risk Scores across health system populations to efficiently identify and intervene on patients likely to have a genomic diagnosis. All of the institutions within the I3P Network will leverage their strong record of collaboration within IGNITE 1 and other NIH funded consortia to accomplish these aims.

项目概要利用基因组变异来制定治疗、预防和诊断决策是一种潜在的临床护理变革方法。然而，临床影响的不确定性经济价值是广泛采用的关键障碍。一体化、个性化、智能处方（I3P）临床试验网络包括三个临床和 IGNITE 2 的社会人口多样化卫生系统：梅哈里地铁综合医院医学院、桑福德健康中心和范德比尔特大学医学中心 (VUMC)。这网络将开发基础设施，以快速招募大量、多样化的患者群体、返回临床指征时的结果，并为医疗保健提供者提供可理解的、试验过程中可实施的指导。第一个目标将制定并实施有效开展涉及基因组医学的实用临床试验的基础设施 I3P 内的不同设置。第二个目标提出一项随机、务实的临床试验通过 IGNITE 2 网络进行多重药物基因组学测试，以建立临床面板测试的效用。最后，I3P 将开发并实施 IGNITE 2 全网络能够有效计算整个卫生系统人群的表型风险评分识别并干预可能进行基因组诊断的患者。所有机构 I3P 网络内的成员将利用他们在 IGNITE 1 内的良好合作记录，其他 NIH 资助的财团来实现这些目标。