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

Abstract

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.

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Fig. 1: Structure of the IGNITE PTN.
Fig. 2: Organization of the Coordinating Center (CC).

Data availability

While this paper does not contain any primary research data, the IGNITE PTN will provide materials the Network has developed upon request. The PTN is particularly interested in supporting those interested in carrying out PCTs with genomic interventions. A goal of the PTN is to always make protocols, consents, clinical decision support rules, and code (where appropriate) available publicly.

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Acknowledgements

This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, U01 HG010248, U01 HG010231, U01 HG0010245, U01 HG010225) and by the NIH IGNITE Network. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Conceptualization: all authors. Writing—original draft: all authors. Writing—review and editing: all authors. Funding acquisition: G.S.G., L.H.C., H.C., R.M.C.-D., P.R.D., M.T.E., B.S.F., C.R.H., J.J., L.A.O., J.P., T.C.S. Project administration: J.K., N.K., E.B.M., W.P., V.M.P., T.K.R.-B., M.A.R., N.S., K.-A.S.-B., S.L.V.D., D.V., K.W., A.G.W., S.V.

Corresponding author

Correspondence to Geoffrey S. Ginsburg.

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Competing interests

L.H.C. has been funded by the NIH and FDA. She has received compensation as a consultant for LexiComp Inc. V.M.P. has has received compensation as an advisory board member of Avalon Healthcare Solutions. G.S.G. has been funded by NIH, the Department of Defense, and Abbott, Inc., and reports consulting for Konica-Minolta, Pappas Ventures, Fabric Genomics, and Peer Medical; he is a founder of Predigen Inc. T.C.S. has been funded by the NIH. He has received compensation as a consultant to Indiana University. He has received reimbursement for travel to a meeting by Tabula Rasa Healthcare. D.V. has been funded by NIH, AHA, AstraZeneca, and Department of Veterans Affairs. He has received compensation as a consultant from United Health Care. A.G.W. has been funded by the Merck & Co., FDA, NIH, the Bill and Melinda Gates Foundation and the State of Florida. The other authors declare no competing interests.

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Ginsburg, G.S., Cavallari, L.H., Chakraborty, H. et al. Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network. Genet Med (2021). https://doi.org/10.1038/s41436-021-01118-9

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