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

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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 implementing genomic medicine in diverse clinical settings outside of specialized care and disseminated its findings to the genomic medicine community .

In August 2016, NHGRI held the workshop entitled "IGNITE and Beyond: The Future of Genome Medicine Implementation" to identify optimal study designs for future genomic medicine implementation program(s). Key recommendations from this workshop include providing flexibility to follow-up single site study observations in genomic medicine implementation with expanded, large-scale studies to confirm findings and decrease bias; fostering collaboration between academic and community centers to increase access to genomic medicine in underrepresented and lower socioeconomic level populations; and partnering with stakeholders including payers and technology companies to get input on study design, conduct, and interpretation to provide the specific evidence needed for genomic medicine sustainability.

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 and a CC to conduct pragmatic clinical trials (PCTs) of genomic medicine interventions.

The goals of these pragmatic clinical trials will be:

  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

The PCTs will be chosen from the protocols proposed by the funded CGs. The IGNITE II Protocol Review Committee (PRC) will evaluate the PCT protocols proposed by each funded CG. Two to three protocols will then be selected based on clinical importance, feasibility of implementation in the funded CGs, potential impact, and cost, and the Steering Committee will adapt and expand each protocol to be implemented Network-wide utilizing the patient populations and multiple Clinical Sites comprising the funded CGs.

Protocols prioritization by the PRC and NHGRI is expected by Spring 2019 and recruitment is planned to begin in late Summer 2019.

Program Contacts

NHGRI Program Directors

Simona Volpi, Pharm.D., Ph.D.
Program Lead, Division of Genomic Medicine
E-mail: simona.volpi@nih.gov

Ebony B. Madden, Ph.D., M.G.C.
Division of Genomic Medicine
E-mail: ebony.madden@nih.gov 

Nicole Lockhart, Ph.D.
Division of Genomics and Society
E-mail: lockhani@mail.nih.gov 

Jeff Struewing, M.D., M.S.
Division of Genomic Medicine
E-mail: struewij@mail.nih.gov

NHGRI Program Analyst

Michelle Cohen
Division of Genome Sciences
E-mail: michelle.cohen2@nih.gov

NHGRI Program Specialist

Sylvia M. Garvey, M.P.H., CPH
Division of Genomic Medicine
E-mail: sylvia.garvey@nih.gov

Last Updated: September 24, 2018