The Implementing GeNomics In pracTiCe (IGNITE) Pragmatic Clinical Trials Network is an NIH-funded network dedicated to supporting the implementation of genomics in healthcare.
The Network is comprised of five research sites, a coordinating center, a steering committee, and working groups. The National Human Genome Research Institute and a data safety and monitoring board provide oversight for all network activity and is intricately involved in all aspects of IGNITE design and operation.
In order to provide the evidence that genomic medicine will improve patient outcomes, IGNITE will conduct 2 – 3 large, network-wide genomic medicine pragmatic clinical trials (PCTs), which will allow for bigger, more efficient clinical trials and help researchers and clinicians understand what to expect in real-world clinical settings. These include GUARDD-US and ADOPT-PGx.
IGNITE also disseminates the methods and best practices its members develop in order to advance the implementation of genomics in healthcare. One outlet for public distribution is the SPARK Toolbox, which provides genomic medicine resources for clinicians and researchers. Another will be the creation of the Genomic Medicine Knowledge Base (GMKB) where ideas can be shared so that everyone can begin to use this in practice, whether in community clinics or academic medical centers.
What are Pragmatic Clinical Trials?
Pragmatic Clinical Trials are "designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens and risks of a biomedical or behvavioral health intervention at the individual or population level."
Source: Califf RM, Sugarman J. 2015. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 12:436–441. doi:10.1177/1740774515598334.
A Depression and Opioid Pragmatic Trial in Pharmacogenomics
Pain and depression are conditions that impact a substantial proportion of the U.S. population, but finding safe, effective drug therapies for both conditions is challenging. ADOPT-PGx is a pragmatic clinical trial that enrolls patients into three pharmacogenomics (PGx)-guided therapy scenarios: acute post-surgical pain, chronic pain, and depression. For each scenario, participants will be randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection ("usual care"). Changes in patient-reported outcomes representing pain and depression control using standard patient-reported outcomes measurement information system (PROMIS) scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization.
Genetic testing to Understand Renal Disease Disparities across the U.S.
Lead Site: Mount Sinai
GUARDD-US 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). The primary outcome is SBP at three months comparing patients with high-risk APOL1 variants (positives) versus no high-risk variants (negatives). The co-primary outcome is three-month SBP in positives versus those receiving delayed testing. Secondary outcomes include renal disease testing, and psycho-behavioral factors. We will re-randomize APOL1 negative patients to a genotype-guided approach to anti-hypertensive therapy versus usual care and compare three-month SBP.
Events and News
Genomic and Precision Medicine Weekly Forum
Calum MacRae, M.D., Ph.D.
Vice Chair for Scientific Innovation, Brigham and Women's Hospital; Associate Professor of Medicine
Harvard Medical School
Overcoming the barriers to clinical whole genome sequencing in routine acute care
When: February 20, 2020
Where: Duke University
Join via WebEx
Meeting Number: 1-855-244-8681
Access Code: 733 677 851
Stakeholder Summit: Federal Regulation of Pharmacogenomic Testing
UF Precision Medicine Program and Precision Medicine Advisors will bring together stakeholders to discuss recent regulation by the FDA and formulate solutions for improving the safety and efficacy of pharmacogenomic tests.
When: Thursday, February 20, 2020; 8 a.m. - noon
Where: Orlando, FL
Clinical Pharmacogenomics Preconference
These sessions will provide the latest update on emerging topics in pharmacogenomics. Attendees will learn from pharmacogenomics implementation leaders about their real world-experiences with using pharmacogenomics in the clinic, describe the regulatory oversight and need for evidence-based pharmacogenomic testing, as well as discuss the hottest topics in clinical pharmacogenomics today. The inaugural Clinical Pharmacogenomics Networking Reception to immediately follow.
When: Thursday, February 20, 2020
Where: Orlando, FL
Fellowship in Genomic Medicine Program Management
The National Human Genome Research Institute (NHGRI) invites qualified physicians, physician assistants, nurse practitioners and genetic counselors to apply to the Fellowship in Genomic Medicine Program Management. This is an NIH coalition consisting of the National Human Genome Research Institute (NHGRI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Minority Health and Health Disparities (NIMHD), and the All of Us Research Program in partnership with the American College of Medical Genetics (ACMG).
The goal of this fellowship is to increase the pool of physicians, physician assistants, nurse practitioners, and genetic counselors trained in managing research and implementation programs in genomic medicine. The fellowship will last 24 months, and will be located primarily in the Bethesda, Maryland area.
Application Deadline: February 14, 2020
IGNITE PI Dr. Joshua Denny to serve as new Chief Executive Officer of All of Us research project
As CEO, Denny will oversee NIH’s efforts to build one of the largest and most comprehensive precision medicine research platforms in the world, in partnership with a diverse network of awardees and participants.
A Crystal Ball for the Decade Ahead
With a new decade dawning, Duke Today asked several Duke professors to hypothetically gaze into their crystal balls to tell us what they see happening in the years ahead. CAGPM director Geoff Ginsburg gave his perspective on what he thinks precision medicine will look like in a decade.
What is the SPARK TOOLBOX?
The SPARK Toolbox reflects a collection of expert consensus regarding special considerations, standard approaches, and best practices in the design, conduct, and reporting of Genomic Medicine. Given the rapid pace of change in this field, this Toolbox will continue to be added to and updated.
SPECIALIZE IN GENOMIC MEDICINE
IGNITE is comprised of five research sites that help promote the mission of the Network through support from a coordinating center, working groups, affiliate members, and an external scientific panel. Each Network site provides educational opportunities that provide an opportunity to learn more about genomics and how to best implement into healthcare.