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
Richard Gibbs, Ph.D.
Director, Human Genome Sequencing Center; Professor of Translational Biology & Molecular Medicine and Integrative Molecular and Biomolecular Sciences; Baylor College of Medicine
When: Thursday, September 19, 2019, noon - 1 P.M.
Where: Duke University
IGNITE Steering Committee Meeting
IGNITE will conduct a a two-day Steering Committee Meeting and joint meeting with the Data and Safety Monitoring Board
When: Wednesday, September 25 - Thursday, September 26, 2019
Where: Silver Spring, MD
Enhancing Scientific Reproducibility through Transparent Reporting – A Workshop
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine is convening a public workshop to discuss the current state of transparency in reporting pre-clinical biomedical research and to explore the possibility of improving the harmonization of guidelines across journals and funding agencies so that biomedical researchers propose and report data in a consistent manner.
When: Wednesday, September 25 - Thursday, September 26, 2019; 8:30 A.M.
Where: Washington, D.C.
NHGRI Stategic Planning Workshop
Genomics in Medicine & Health
NHGRI is in the middle of a new round of strategic planning that will establish a ‘2020 vision for genomics’ and culminate in the publication of a new NHGRI strategic plan in October 2020 and is soliciting input from the broader research and public communities to help shape the 2020 strategic plan.
When: Thursday, Sept. 26 - Friday, Sept. 27, 2019, 8 A.M. - 5 P.M. both days
Where: Bethesda, MD
The Lancet publishes series of 5 papers featuring IGNITE researchers
Members of the IGNITE Network were involved in three of the five publications in this series. Genomic Medicine 1: Opportunities, resources and techniques for implementing genomics in clinical care describes the major types and measurement tools of genomic variation that are currently of clinical importance, reviews approaches to interpreting genomic sequence variants, identifies publicly available tools and resources for genomic test interpretation, and discusses several key barriers in using genomic information in routine clinical practice. Genomic Medicine 4: Family health history: Underused for actionable risk assessment discusses the importance of family health history as a tool for risk assessment for common chronic diseases. Genomic Medicine 5: Building evidence and measuring clinical outcomes for genomic medicine reviews clinical outcome studies in genomic medicine and discusses the important features and key challenges to building evidence for next generation sequencing in the context of routine patient care.
Henry Ong to present at the AMIA 2019 Annual Symposium
Dr. Henry Ong will present his research, Extracting Drug Exposure Epochs and Drug Response Outcomes from Electronic Health Records, at the American Medical Informatics Association (AMIA) 2019 Annual Symposium on November 18. His research was selected out of a record number of submissions to AMIA this year -- over 1,200 across all categories!
Dr. Ong is a project manager in the IGNITE Network. He also serves as a project manager at the Vanderbilt Institute for Clinical and Translational Research. The AMIA 2019 Symposium will be held in Washington, D.C., November 16-20. This year's theme, Informatics: From Data to Knowledge to Action," will build on more than 40 years of sharing pioneering research and insights for leveraging information to improve human health.
NIH funds clinical trials using genomics to treat chronic diseases
The National Institutes of Health will fund clinical trials to assess the benefits, applicability and efficacy of applying genomic medicine interventions to improve management of diseases such as high blood pressure, depression and chronic pain. The trials are part of the second phase of the Implementing Genomics in Practice (IGNITE) Network with a total investment of $42 million over five years, pending the availability of funds. The trials will begin in 2020. Read more
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.