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Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network.
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; Kucher, Natalie; Madden, Ebony B; Orlando, Lori A; Parker, Wanda; Peterson, Josh; Pratt, Victoria M; Rakhra-Burris, Tejinder K; Ramos, Michelle A; Skaar, Todd C; Sperber, Nina; Steen-Burrell, Kady-Ann; Van Driest, Sara L; Voora, Deepak; Wiisanen, Kristin; Winterstein, Almut G; Volpi, Simona.
Affiliation
  • Ginsburg GS; Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA. Geoffrey.ginsburg@duke.edu.
  • Cavallari LH; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.
  • Chakraborty H; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.
  • Dexter PR; School of Medicine, Indiana University, Indianapolis, IN, USA.
  • Eadon MT; Division of Clinical Pharmacology, Indiana University, Indianapolis, IN, USA.
  • Ferket BS; Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA.
  • Horowitz CR; Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA.
  • Johnson JA; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.
  • Kannry J; Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA.
  • Kucher N; Division of Genomic Medicine, National Human Genome Research Institute, NIH, Bethesda, MD, USA.
  • Madden EB; Division of Genomic Medicine, National Human Genome Research Institute, NIH, Bethesda, MD, USA.
  • Orlando LA; Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA.
  • Parker W; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Peterson J; Department of Biomedical Informatics, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Pratt VM; Department of Medical and Molecular Genetics, Indiana University, Indianapolis, IN, USA.
  • Rakhra-Burris TK; Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA.
  • Ramos MA; Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA.
  • Skaar TC; Division of Clinical Pharmacology, Indiana University, Indianapolis, IN, USA.
  • Sperber N; Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA.
  • Steen-Burrell KA; Department of Population Health Sciences, Duke Margolis Center for Health Policy, Durham VA Health Services Research & Development Service, Duke Center for Applied Genomics & Precision Medicine, Durham, NC, USA.
  • Van Driest SL; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Voora D; Department of Pediatrics, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Wiisanen K; Duke Center for Applied Genomics & Precision Medicine, Duke University, Durham, NC, USA.
  • Winterstein AG; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.
  • Volpi S; Department of Pharmaceutical Outcomes and Policy, Center for Drug Evaluation and Safety, University of Florida, Gainesville, FL, USA.
Genet Med ; 23(7): 1185-1191, 2021 07.
Article in En | MEDLINE | ID: mdl-33782552
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.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Decision Support Systems, Clinical / Genomics Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Genet Med Journal subject: GENETICA MEDICA Year: 2021 Document type: Article Affiliation country: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Decision Support Systems, Clinical / Genomics Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Genet Med Journal subject: GENETICA MEDICA Year: 2021 Document type: Article Affiliation country: United States