Integrated, Individualized, Intelligent Prescribing (I3P)

人类基因组计划产生的一个广泛的愿景是使用新的可用的基因 指导个别患者的预防和治疗决策的信息。一 测试这一概念似乎特别成熟的治疗领域是药物基因组学，即 治疗反应的变异性包括基因组成分。常见的变种 生殖系和体细胞肿瘤基因都是越来越公认的致病因素 药物反应的可变性，因此，对基因引导治疗的建议是 被颁布的。通过在多个基因组网络中的领导地位，范德比尔特一直在 药物基因组学发现和将这一知识转化为临床的前沿 在当地练习。然而，很少有机构或从业者拥有适当的程序和工具 将基因数据纳入常规药物处方。在这项提案中，我们朝着这个方向发展 通过建立将基因组医学整合到不同医疗保健中的计划进行实践 设置。集成、个性化和智能预描述(I3P)项目的目的是 进行多点演示，将基因数据集成到电子健康中 记录(EHR)可以改善医疗保健。我们将建立流程和基础设施 将临床基因检测、结果报告和决策支持传播到 多样化的医院和电子病历环境。该应用程序侧重于药物基因组学，给出了 药品不良反应(ADRs)是导致发病率和死亡率的主要原因， 美国食品和药物管理局(FDA)纳入的公认变种数量不断增加 标签作为有效性和毒性的介体，以及相对缺乏附着的耻辱 “药物起源”中的变种携带者。该项目将建立在两个正在进行的临床 范德比尔特的基因分型工作：1)用于增强决策的药物基因组资源 护理和治疗(预测)计划，该计划前瞻性地测试184名患者的高价值 生殖系药物基因组变异包括与氯吡格雷、华法林和 辛伐他汀；以及2)个人癌症医学倡议(PCMI)，它通常执行 肺癌和黑色素瘤的多重肿瘤基因突变检测以指导治疗。I3P将 利用以下网站上的现有专业知识、信息学和实验室基础设施和资源 范德比尔特公司将在早些时候在三个不同的医疗系统中实施基因组医学 这些医疗保健系统包括服务不足的少数族裔人口(纳什维尔 梅哈里医学院总医院)，军事人口(纳什维尔退伍军人事务部 医疗中心)和社区卫生系统(奥罗拉卫生保健)。

A widely-held vision arising from the Human Genome Project is use of newly available genetic information to guide preventive and therapeutic decision making in individual patients. One therapeutic area that seems particularly ripe to test this concept is pharmacogenomics, the idea that variability in therapeutic response includes a genomic component. Common variation in both germline and somatic tumor genes is an increasingly well-recognized contributor to variability in drug response, and as a result, recommendations for genotype-guided therapy are being promulgated. Through leadership in multiple genomic networks, Vanderbilt has been at the forefront of pharmacogenomic discovery and translation of this knowledge into clinical practice locally. However, few institutions or practitioners have the procedures and tools in place to incorporate genetic data into routine drug prescribing. In this proposal, we move toward this practice by establishing a program for integrating genomic medicine in diverse healthcare settings. The purpose of the Integrated, Individualized, and Intelligent Prescribing (I3P) project is to perform a multi-site demonstration that integrating genetic data within electronic health records (EHRs) can improve healthcare. We will establish the processes and infrastructure necessary to disseminate clinical genetic testing, results reporting, and decision support into diverse hospital and EHR environments. This application focuses on pharmacogenomics, given the role of adverse drug reactions (ADRs) as major causes of morbidity and mortality, the increasing number of recognized variants included in US Food and Drug Administration (FDA) labels as mediators of both efficacy and toxicity, and the relative lack of stigma attached to carriers of variants in "pharmacogenes." The project will build on two ongoing, clinical genotyping efforts at Vanderbilt: 1) the Pharmacogenomic Resource for Enhanced Decisions In Care and Treatment (PREDICT) program, which prospectively tests patients for 184 high-value germline pharmacogenomic variants including those associated with clopidogrel, warfarin and simvastatin; and 2) the Personal Cancer Medicine Initiative (PCMI), which routinely performs multiplex tumor gene mutation testing in lung cancer and melanoma to direct therapy. I3P will leverage the existing expertise, informatics, and laboratory infrastructure and resources at Vanderbilt to implement genomic medicine in three diverse healthcare systems at "early adopter" sites. These healthcare systems include underserved, minority populations (Nashville General Hospital at Meharry Medical College), military populations (Nashville Veterans Affairs Medical Center), and a community health system (Aurora Health Care).