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

项目摘要 使用基因组变异来调整治疗，预防和诊断决策是一个 临床护理的潜在变革性方法。然而，临床影响的不确定性 和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：Meharry的Metro综合医院 医学院，桑福德健康和范德比尔特大学医学中心（VUMC）。的 网络将开发基础设施，以快速招募大量不同的患者人群， 结果在临床指征时，并提供医疗保健提供者可以理解的， 在审判过程中提供指导。第一个目标将制定和实施 基础设施，以有效地进行涉及基因组医学的实用临床试验， I3P中的各种设置。第二个目标是提出一个随机的、实用的临床试验 IGNITE 2网络中的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将开发和实施IGNITE 2全网络 能够计算卫生系统人群的表型风险评分， 识别和干预可能有基因组诊断的患者。的所有机构 在I3P网络中，将利用他们在IGNITE 1中的良好合作记录， 其他NIH资助的财团来实现这些目标。

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.