NEW YORK (GenomeWeb) – The National Institutes of Health announced that it has earmarked $2.6 million to fund groups that will participate in the National Human Genome Research Institute's Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Network initiative to conduct studies evaluating genomic medicine in routine clinical care.
The original IGNITE network was established in 2013 to develop new methods for implementing genomic medicine in diverse clinical settings outside of specialized care and disseminate its findings to the genomic medicine community. IGNITE II aims to build on this work with a network of groups that will run pragmatic clinical trials (PCTs) of genomic medicine interventions previously demonstrated to be feasible and of potential value in clinical care.
Broadly, the PCTs are expected to measure the clinical utility and cost-effectiveness of genomic medicine interventions; assess approaches for real-world application of genomic medicine in diverse clinical settings; and produce generalizable knowledge on the types of genomic medicine interventions requiring randomized clinical trials and effective methods for conducting them. To ensure diversity, these studies will be required to include significant numbers of patients who come from racial or ethnic minority populations, underserved populations, or populations who experience poorer medical outcomes.
The NIH has committed $2 million in fiscal 2018 to fund four to six clinical groups to run the PCTs, as well as $645,000 for a coordinating center that will help adapt clinical protocols for implementation across the IGNITE II network, as well as perform interim and final analyses of data from each PCT.