Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Network

IGNITE II supports a network of multi-site clinical groups involving diverse settings and populations to conduct 2-3 pragmatic clinical trials of genomic medicine interventions.

Overview

The Implementing Genomic in Practice (IGNITE) Network was established in 2013 (RFA-HG-12-006, RFA-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.

The next phase of IGNITE, IGNITE II (RFA-HG-17-008, RFA-HG-17-009, and RFA-HG-17-010) will support a network of multi-site Clinical Groups (CGs) involving diverse settings and populations to conduct 2-3 pragmatic clinical trials of genomic medicine interventions. The goals of these pragmatic clinical trials will be:

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.
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-12-006, RFA-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.

The next phase of IGNITE, IGNITE II (RFA-HG-17-008, RFA-HG-17-009, and RFA-HG-17-010) will support a network of multi-site Clinical Groups (CGs) involving diverse settings and populations to conduct 2-3 pragmatic clinical trials of genomic medicine interventions. The goals of these pragmatic clinical trials will be:

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.

To produce generalizable knowledge on the types of genomic medicine interventions requiring randomized clinical trials and effective methods for conducting them

Investigators

Study Investigators

Principal Investigator: Julie Johnson, Pharm.D., University of Florida
Principal Investigator: Todd Skaar, Ph.D., Indiana University
MPI: Paul Dexter, M.D., Indiana University
Principal Investigator: Carol Horowitz, M.P.H., M.D., Mount Sinai School of Medicine
Principal Investigator: Lori Orlando, M.H.S., M.D., Duke University
Principal Investigator: Josh Peterson, M.D., M.P.H., Vanderbilt University Medical Center
MPI: Sara Van Driest, M.D., Ph.D., Vanderbilt University Medical Center

Coordinating Center

Principal Investigator: Geoffrey Ginsburg, MD, PhD, Duke University School of Medicine
MPI: Hrishikesh Chakraborty, M.S., PhD, Duke University School of Medicine

Investigators
Study Investigators

Principal Investigator: Julie Johnson, Pharm.D., University of Florida

Principal Investigator: Todd Skaar, Ph.D., Indiana University
MPI: Paul Dexter, M.D., Indiana University

Principal Investigator: Carol Horowitz, M.P.H., M.D., Mount Sinai School of Medicine

Principal Investigator: Lori Orlando, M.H.S., M.D., Duke University

Principal Investigator: Josh Peterson, M.D., M.P.H., Vanderbilt University Medical Center
MPI: Sara Van Driest, M.D., Ph.D., Vanderbilt University Medical Center

Coordinating Center

Principal Investigator: Geoffrey Ginsburg, MD, PhD, Duke University School of Medicine
MPI: Hrishikesh Chakraborty, M.S., PhD, Duke University School of Medicine