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

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Date

2021-03-29

Authors

Ginsburg, Geoffrey S
Cavallari, Larisa H
Chakraborty, Hrishikesh
Cooper-DeHoff, Rhonda M
Dexter, Paul R
Eadon, Michael T
Ferket, Bart S
Horowitz, Carol R
Johnson, Julie A
Kannry, Joseph

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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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Citation

Published Version (Please cite this version)

10.1038/s41436-021-01118-9

Publication Info

Ginsburg, Geoffrey S, Larisa H Cavallari, Hrishikesh Chakraborty, Rhonda M Cooper-DeHoff, Paul R Dexter, Michael T Eadon, Bart S Ferket, Carol R Horowitz, et al. (2021). Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network. Genetics in medicine : official journal of the American College of Medical Genetics. 10.1038/s41436-021-01118-9 Retrieved from https://hdl.handle.net/10161/22474.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Ginsburg

Geoffrey Steven Ginsburg

Adjunct Professor in the Department of Medicine

Dr. Geoffrey S. Ginsburg's research interests are in the development of novel paradigms for developing and translating genomic information into medical practice and the integration of personalized medicine into health care.

Chakraborty

Hrishikesh Chakraborty

Professor of Biostatistics & Bioinformatics
Orlando

Lori Ann Orlando

Professor of Medicine

Dr. Lori A. Orlando, MD MHS MMCI is a Professor of Medicine and Director of the Precision Medicine Program in the Center for Applied Genomics and Precision Medicine at Duke University. She attended Tulane Medical Center for both medical school (1994-1998) and Internal Medicine residency (1998-2000). There she finished AOA and received a number of awards for teaching and clinical care from the medical school and the residency programs, including the Musser-Burch-Puschett award in 2000 for academic excellence. After completing her residency, she served as Chief Medical Resident in Internal Medicine (2001) and then completed a Health Services Research Fellowship at Duke University Medical Center (2002-2004). In 2004 she also received her MHS from the Clinical Research Training Program at Duke University and joined the academic faculty at Duke. In 2005 she received the Milton W. Hamolsky Award for Outstanding Junior Faculty by the Society of General Internal Medicine. Her major research interests are decision making and patient preferences, implementation research, risk stratification for targeting preventive health services, and decision modeling. From 2004-2009 she worked with Dr. David Matchar in the Center for Clinical Heath Policy Research (CCHPR), where she specialized in decision modeling, decision making, and technology assessments. In 2009 she began working with Dr. Geoffrey Ginsburg in what is now the Center for Applied Genomics and Precision Medicine (CAGPM) and in 2014 she became the director of the Center’s Precision Medicine Program. Since joining the CAGPM she has been leading the development and implementation of MeTree, a patient-facing family health history based risk assessment and clinical decision support program designed to facilitate the uptake of risk stratified evidence-based guidelines. MeTree was designed to overcome the major barriers to collecting and using high quality family health histories to guide clinical care and has been shown to be highly effective when integrated into primary care practices. This effort started with the Genomic Medicine Model, a multi-institutional project, whose goal was to implement personalized medicine in primary care practices. The success of that project has led to funding as part of NHGRI’s IGNITE (Implementing Genomics in Clinical Practice) network. She is currently testing methods for integrating patient preferences and decision making processes into clinical decision support recommendations for patients and providers to facilitate management of patients’ risk for chronic disease using mHealth and other behavioral interventions.

Sperber

Nina Sperber

Associate Professor in Population Health Sciences

My research career has centered on understanding how to improve delivery of new evidence-based practices in health care systems. I work in health services research and development for the VA health care system and have an academic appointment with the Duke University School of Medicine. I create study designs that integrate qualitative and quantitative methods (mixed-methods) and apply Implementation Science and System Science approaches. I currently have a developing body of academic work that uses participatory system dynamics modeling as a strategy to identify system level factors that affect development and implementation of equitable AI tools. For the VA health care system, I direct a cross-functional team that conducts rapid turnaround projects for high priority needs by VHA national, regional, and facility leaders.

 

Voora

Deepak Voora

Associate Professor of Medicine

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