Embedding Pharmacogenotyping in an Integrated Health System for the Underserved

个性化医疗的目标是实现生物标志物药理学、分子生物学方面的进步 诊断学和基因组学来改善公共卫生。为了实现这门科学的全部好处， 至关重要的是，在实验环境中和小规模上取得的科学进步应扩大到 社区实践，并可以提出商业案例来支持这种传播。重要的是 关键的创新将从单个医院扩展到大型医疗保健系统，特别是那些 包括服务不足的人群。许多科学进步绕过了服务不足的人群， 结果导致护理不平等和成本效率低下。2011年，印第安纳州个性化医疗研究所 (IPM)是作为一个学术家的基础和临床研究人员致力于研究， 个性化医疗IPM的一个具体目标是将这门科学推向临床实践。为此， 该提案的目的是在大型安全网卫生保健系统中试行基因组平台， 衡量这样做的经济成本和临床结果。Eskenazi Health处理超过120万人 每年的门诊量和> 15，000次入院，支付者组合包括45%的未保险者，26%的未保险者， 医疗保险和18%的医疗保险患者。在这项提案中，IPM将与Eskenazi Health和 Regenstrief研究所招募了一个新的“Eskenazi队列”基因型患者。一个多学科小组， 临床医生和信息科学家将试行一种创新的方法， 药物基因组学Regenstrief研究所在医疗创新方面有着良好的记录。 信息学，并创造了一个理想的环境，在其中评估真实的临床结果。具体 本提案的目的是：1）检验CLIA认证的基因分型检测针对24 广泛使用的药物与医院和门诊经济成本的显著降低有关 1年以上;和2）测试此类药物遗传学测试是否与显著改善相关 1年以上的临床结果。患者将随机分配至干预组，包括 药物基因分型，在病历中插入结果并传播相关结果， 决策算法提供者（n=2000例患者），或常规护理（n=4000例患者）。本试验将 在Eskenazi初级保健诊所和6个专科诊所实施。经济成本和临床 结果包括门诊访视、住院、住院时间、药物不良反应、发病率和 死亡率，将进行前瞻性随访，并在两组之间进行比较。为了保持这一努力，我们将 将这项测试的使用范围扩大到IU Health，以及附属的NCI西蒙癌症中心和莱利医院， 孩子这项研究的数据将首次为以下方面制定一个客观的商业案例： 基于真实的世界成本和结果的药物基因组学个性化。

The goal of Personalized Medicine is to implement advances in biomarker pharmacology, molecular diagnostics and genomics to improve public health. For the full benefits of this science to be realized, it is critical that scientific advances made in experimental settings and on a small scale be extended to community practice and that a business case can be made to support such dissemination. It is important that key innovations be extended beyond individual hospital settings to large health care systems, especially those that include underserved populations. Many scientific advances bypass underserved populations, and as a result inequalities of care and cost inefficiencies result. In 2011, the Indiana Institute for Personalized Medicine (IPM) was created to serve as an academic home for basic and clinical researchers committed to research in personalized medicine. A specific goal of the IPM is to move this science towards clinical practice. To that end, the purpose of this proposal is to pilot a genomic platform in a large safety-net health care system, and to measure the economic costs and clinical outcomes of doing so. Eskenazi Health handles over 1.2 million outpatient visits per year and > 15,000 admissions annually, with a payer mix that include 45% uninsured, 26% Medicaid and 18% Medicare patients. In this proposal, the IPM will partner with Eskenazi Health and the Regenstrief Institute to recruit a new "Eskenazi cohort" of genotyped patients. A multidisciplinary group of clinicians and information scientists will pilot an innovative approach to the implementation of pharmacogenomic science. The Regenstrief Institute has a proven track record of innovation in medical informatics, and has created an ideal environment in which to assess real clinical outcomes. The specific aims of this proposal will be: 1) To test the hypothesis that a CLIA certified genotyping test targeted at 24 widely used drugs is associated with significant reductions in hospital and outpatient economic costs incurred over 1 year; and 2) To test whether such pharmacogenetic testing is associated with significant improvements in clinical outcomes over 1 year. Patients will be randomized either to an intervention arm, involving pharmacogenotyping, insertion of results in the medical record and dissemination of relevant results and decision algorithms to providers (n=2000 patients), or to usual care (n=4000 patients). This trial will be implemented in Eskenazi primary care clinics and 6 specialty clinics. Economic costs and clinical outcomes including clinic visits, hospital admissions, length of stay, adverse drug reactions, morbidity and mortality, will be followed prospectively and compared between the two groups. To sustain this effort, we will extend access to this testing to IU Health, and the affiliated NCI Simon Cancer Center and Riley Hospital for Children. Data from this study will allow for the first time the development of an objective business case for pharmacogenomic personalization based on real world costs and outcomes.