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Implementing Genomics in Practice (IGNITE) Pragmatic Clinical Trials Network (PTN)

The IGNITE PTN supports a network of multi-site clinical groups involving diverse settings and populations to conduct two pragmatic clinical trials of genomic medicine interventions.

Overview

The Implementing Genomic in Practice (IGNITE) Network was established in 2013 (RFA-HG-12-006RFA-HG-12-007 and RFA-HG-13-004) to develop methods for incorporating genomic information into clinical care and explore the methods for effective implementation, diffusion, and sustainability in diverse clinical settings. The first phase of the network, IGNITE I, was a consortium of collaborative genomic medicine pilot Demonstration Projects designed to demonstrate the feasibility of, and develop methods for, incorporating an individual patient's genomic findings into his or her clinical care.

Building on the successful genomic medicine projects of IGNITE I, the next phase of IGNITE (RFA-HG-17-008RFA-HG-17-009, and RFA-HG-17-010) began in 2018. The network comprises five multi-site Clinical Groups (CGs) and one Coordinating Center (CC) involving diverse settings and populations to conduct pragmatic clinical trials of genomic medicine interventions. The two CG Funding Opportunity Announcements (FOAs) required each applicant to submit a proposed pragmatic clinical trial that would be evaluated in review and selected by an NHGRI-convened Protocol Review Committee (PRC). The PRC ultimately selected two studies based on clinical importance, feasibility of implementation in the funded CGs, potential impact, and cost. The goals of these pragmatic clinical trials are:

  1. To measure the clinical utility and cost-effectiveness of genomic medicine interventions.
  2. To assess approaches for real-world application of genomic medicine in diverse clinical settings.
  3. To produce generalizable knowledge on the types of genomic medicine interventions requiring randomized clinical trials and effective methods for conducting them.
  • Overview

    The Implementing Genomic in Practice (IGNITE) Network was established in 2013 (RFA-HG-12-006RFA-HG-12-007 and RFA-HG-13-004) to develop methods for incorporating genomic information into clinical care and explore the methods for effective implementation, diffusion, and sustainability in diverse clinical settings. The first phase of the network, IGNITE I, was a consortium of collaborative genomic medicine pilot Demonstration Projects designed to demonstrate the feasibility of, and develop methods for, incorporating an individual patient's genomic findings into his or her clinical care.

    Building on the successful genomic medicine projects of IGNITE I, the next phase of IGNITE (RFA-HG-17-008RFA-HG-17-009, and RFA-HG-17-010) began in 2018. The network comprises five multi-site Clinical Groups (CGs) and one Coordinating Center (CC) involving diverse settings and populations to conduct pragmatic clinical trials of genomic medicine interventions. The two CG Funding Opportunity Announcements (FOAs) required each applicant to submit a proposed pragmatic clinical trial that would be evaluated in review and selected by an NHGRI-convened Protocol Review Committee (PRC). The PRC ultimately selected two studies based on clinical importance, feasibility of implementation in the funded CGs, potential impact, and cost. The goals of these pragmatic clinical trials are:

    1. To measure the clinical utility and cost-effectiveness of genomic medicine interventions.
    2. To assess approaches for real-world application of genomic medicine in diverse clinical settings.
    3. To produce generalizable knowledge on the types of genomic medicine interventions requiring randomized clinical trials and effective methods for conducting them.

Genetic Testing to Understand and Address Renal Disease Disparities in the United States (GUARDD-US)

GUARDD-US (ClinicalTrials.gov Identifier: NCT04191824) is a pragmatic clinical trial that aims to determine the effect of returning apolipoprotein L1 (APOL1) genetic risk information to hypertensive African ancestry patients and their primary care providers on systolic blood pressure (SBP).

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (ADOPT-PGx)

ADOPT-PGx (ClinicalTrials.gov Identifier: NCT04445792) is a pragmatic clinical trial comparing genotype-guided drug therapy versus usual approaches to drug therapy selection ("usual care") for acute post-surgical pain, chronic pain, and depression via changes in patient-reported outcomes representing pain and depression control.

Data and Safety Monitoring Board (DSMB)

Both GUARDD-US and ADOPT-PGx protocol development and trial data are reviewed by the independent, NHGRI-convened DSMB. The following members serve on the DSMB:

  • Bruce Korf (Chair), MD, PhD, University of Alabama
  • Karen Johnson, MD, MPH, University of Tennessee Health Science Center
  • James Neaton, PhD, University of Minnesota
  • Peter O’Donnell, MD, University of Chicago
  • Mary Relling, PharmD, St. Jude Children’s Research Hospital
  • Jordan Smoller, MD, ScD, Massachusetts General Hospital
  • Timothy A. Thornton, PhD, University of Washington
  • Stephen Wisniewski, PhD, Pittsburgh University
  • Data and Safety Monitoring Board (DSMB)

    Both GUARDD-US and ADOPT-PGx protocol development and trial data are reviewed by the independent, NHGRI-convened DSMB. The following members serve on the DSMB:

    • Bruce Korf (Chair), MD, PhD, University of Alabama
    • Karen Johnson, MD, MPH, University of Tennessee Health Science Center
    • James Neaton, PhD, University of Minnesota
    • Peter O’Donnell, MD, University of Chicago
    • Mary Relling, PharmD, St. Jude Children’s Research Hospital
    • Jordan Smoller, MD, ScD, Massachusetts General Hospital
    • Timothy A. Thornton, PhD, University of Washington
    • Stephen Wisniewski, PhD, Pittsburgh University

Investigators

Coordinating Center

The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination

  • Geoffrey Ginsburg, M.D., Ph.D., Duke University School of Medicine
  • Hrishikesh Chakraborty, M.S., Ph.D., Duke University School of Medicine
     

Clinical Groups

Sparking Advancements in Genomic Medicine

  • Julie Johnson, Pharm.D., University of Florida
  • Lari Cavallari, Pharm.D., University of Florida
     

Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana

  • Todd Skaar, Ph.D., Indiana University
  • Paul Dexter, M.D., Indiana University
     

GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City

  • Carol Horowitz, M.D., M.P.H., Mount Sinai School of Medicine
     

Building and Deploying a Genomic-Medicine Risk Assessment Model for Diverse Primary Care Populations

  • Lori Orlando, M.H.S., M.D., Duke University
     

Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trial Network

  • Josh Peterson, M.D., M.P.H., Vanderbilt University Medical Center
  • Sara Van Driest, M.D., Ph.D., Vanderbilt University Medical Center
  • Investigators

    Coordinating Center

    The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination

    • Geoffrey Ginsburg, M.D., Ph.D., Duke University School of Medicine
    • Hrishikesh Chakraborty, M.S., Ph.D., Duke University School of Medicine
       

    Clinical Groups

    Sparking Advancements in Genomic Medicine

    • Julie Johnson, Pharm.D., University of Florida
    • Lari Cavallari, Pharm.D., University of Florida
       

    Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana

    • Todd Skaar, Ph.D., Indiana University
    • Paul Dexter, M.D., Indiana University
       

    GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City

    • Carol Horowitz, M.D., M.P.H., Mount Sinai School of Medicine
       

    Building and Deploying a Genomic-Medicine Risk Assessment Model for Diverse Primary Care Populations

    • Lori Orlando, M.H.S., M.D., Duke University
       

    Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trial Network

    • Josh Peterson, M.D., M.P.H., Vanderbilt University Medical Center
    • Sara Van Driest, M.D., Ph.D., Vanderbilt University Medical Center

Funding Opportunities

There are no funding opportunities at this time.

Program Staff

Simona Volpi
Simona Volpi, Ph.D.
  • Program Director
  • Division of Genomic Medicine
Ebony B. Madden, Ph.D.
Ebony B. Madden, Ph.D.
  • Program Director
  • Division of Genomic Medicine
Natalie Kucher
Natalie Kucher
  • Scientific Program Analyst
  • Division of Genome Sciences

Last updated: September 29, 2020