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

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.

Figure 1:

Structure of the IGNITE PTN. The coordinating center (Duke University) is at the center. 5 clinical groups (Duke University, Indiana University, Mount Sinai, University of Florida, and Vanderbilt) are represented in the surrounding circle. The relationship to NIH is at the top. On the left are the network working groups that may change over time. On the right are major standing committees and boards. The two PCTs are at the bottom.

Figure 2.

Organization of the coordinating center (CC). The CC cores are in the main box and its relationship to the NIH (above) and to the working groups and clinical groups is below.