Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network.

Journal Article (Journal Article;Pragmatic Clinical Trial)

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Full Text

Duke Authors

Cited Authors

  • Ginsburg, GS; Cavallari, LH; Chakraborty, H; Cooper-DeHoff, RM; Dexter, PR; Eadon, MT; Ferket, BS; Horowitz, CR; Johnson, JA; Kannry, J; Kucher, N; Madden, EB; Orlando, LA; Parker, W; Peterson, J; Pratt, VM; Rakhra-Burris, TK; Ramos, MA; Skaar, TC; Sperber, N; Steen-Burrell, K-A; Van Driest, SL; Voora, D; Wiisanen, K; Winterstein, AG; Volpi, S; IGNITE PTN,

Published Date

  • July 2021

Published In

Volume / Issue

  • 23 / 7

Start / End Page

  • 1185 - 1191

PubMed ID

  • 33782552

Pubmed Central ID

  • PMC8263480

Electronic International Standard Serial Number (EISSN)

  • 1530-0366

Digital Object Identifier (DOI)

  • 10.1038/s41436-021-01118-9

Language

  • eng

Conference Location

  • United States