Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA.
Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.
Genet Med. 2021 Jul;23(7):1185-1191. doi: 10.1038/s41436-021-01118-9. Epub 2021 Mar 29.
A critical gap in the adoption of genomic medicine into medical practice is the need for the rigorous evaluation of the utility of genomic medicine interventions.
The Implementing Genomics in Practice Pragmatic Trials Network (IGNITE PTN) was formed in 2018 to measure the clinical utility and cost-effectiveness of genomic medicine interventions, to assess approaches for real-world application of genomic medicine in diverse clinical settings, and to produce generalizable knowledge on clinical trials using genomic interventions. Five clinical sites and a coordinating center evaluated trial proposals and developed working groups to enable their implementation.
Two pragmatic clinical trials (PCTs) have been initiated, one evaluating genetic risk APOL1 variants in African Americans in the management of their hypertension, and the other to evaluate the use of pharmacogenetic testing for medications to manage acute and chronic pain as well as depression.
IGNITE PTN is a network that carries out PCTs in genomic medicine; it is focused on diversity and inclusion of underrepresented minority trial participants; it uses electronic health records and clinical decision support to deliver the interventions. IGNITE PTN will develop the evidence to support (or oppose) the adoption of genomic medicine interventions by patients, providers, and payers.
将基因组医学纳入医疗实践的一个关键差距是需要严格评估基因组医学干预措施的效用。
实施基因组医学实践实用临床试验网络（IGNITE PTN）于 2018 年成立，旨在衡量基因组医学干预措施的临床效用和成本效益，评估在不同临床环境中实际应用基因组医学的方法，并就使用基因组干预措施进行临床试验产生可推广的知识。五个临床站点和一个协调中心评估了试验提案并成立了工作组以使其得以实施。
已经启动了两项实用临床试验（PCT），一项评估了非裔美国人高血压管理中遗传风险 APOL1 变异，另一项评估了药物遗传学检测在治疗急性和慢性疼痛以及抑郁症方面的应用。
IGNITE PTN 是一个开展基因组医学实用临床试验的网络；它专注于多样性和代表性不足的少数族裔试验参与者的纳入；它使用电子健康记录和临床决策支持来提供干预措施。IGNITE PTN 将为患者、提供者和支付者采用基因组医学干预措施提供支持（或反对）的证据。
