TY - JOUR
T1 - Establishing the value of genomics in medicine
T2 - the IGNITE Pragmatic Trials Network
AU - the IGNITE PTN
AU - Ginsburg, Geoffrey S.
AU - Cavallari, Larisa H.
AU - Chakraborty, Hrishikesh
AU - Cooper-DeHoff, Rhonda M.
AU - Dexter, Paul R.
AU - Eadon, Michael T.
AU - Ferket, Bart S.
AU - Horowitz, Carol R.
AU - Johnson, Julie A.
AU - Kannry, Joseph
AU - Kucher, Natalie
AU - Madden, Ebony B.
AU - Orlando, Lori A.
AU - Parker, Wanda
AU - Peterson, Josh
AU - Pratt, Victoria M.
AU - Rakhra-Burris, Tejinder K.
AU - Ramos, Michelle A.
AU - Skaar, Todd C.
AU - Sperber, Nina
AU - Steen-Burrell, Kady Ann
AU - Van Driest, Sara L.
AU - Voora, Deepak
AU - Wiisanen, Kristin
AU - Winterstein, Almut G.
AU - Volpi, Simona
AU - Montgomery, Aisha
AU - Kitzman, Heather
AU - Sadeghpour, Azita
AU - Voora, Deepak
AU - Ginsburg, Geoffrey S.
AU - Chakraborty, Hrishikesh
AU - Steen-Burrell, Kady Ann
AU - Orlando, Lori A.
AU - Garrett-Mead, Nancy
AU - Sperber, Nina
AU - Wu, R. Ryanne
AU - Rakhra-Burris, Tejinder
AU - Parker, Wanda
AU - Eadon, Michael T.
AU - Dexter, Paul
AU - Lynch, Sheryl
AU - Skaar, Todd
AU - Pratt, Victoria
AU - Nauman, Beth
AU - Johnson, Erica
AU - Ferket, Bart
AU - Horowitz, Carol R.
AU - Kannry, Joseph
AU - Calman, Neil
N1 - Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to the American College of Medical Genetics and Genomics.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85103603563&partnerID=8YFLogxK
U2 - 10.1038/s41436-021-01118-9
DO - 10.1038/s41436-021-01118-9
M3 - Article
C2 - 33782552
AN - SCOPUS:85103603563
SN - 1098-3600
VL - 23
SP - 1185
EP - 1191
JO - Genetics in Medicine
JF - Genetics in Medicine
IS - 7
ER -