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
NIH Collaboratory Grand Rounds
Moving Beyond Return of Research Results to Return of Value
Speaker: Consuelo H. Wilkins, M.D., MSCI
Vice President for Health Equity, Vanderbilt University Medical Center
Executive Director, Meharry-Vanderbilt Alliance
When: Friday, June 28, 1 - 2 P.M. EST
IGNITE Steering Committee Meeting
IGNITE will conduct a a two-day Steering Committee Meeting
When: Thursday, July 25 - Friday, July 26, 2019
Where: Orlando, Florida
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
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
Three IGNITE PIs presented at Precision Medicine Conference
Julie Johnson, PharmD, Carol Horowitz, M.D., M.P.H., and Josh Denny, M.D., were three of the presenters at the University of Florida Precision Medicine Conference, held March 6-7, 2019 in Orlando, Florida. This conference brings together clinicians, researchers and other thought leaders from medicine and pharmacy to receive cutting edge guidance from professionals with experience implementing genomic medicine and pharmacogenomics in a variety of settings.
PHASeR: A collaboration in PGx to help veterans
There are about 15 million cancer survivors in the United States; about 400,000 of them are also veterans in the Veterans Affairs (VA) system. As more people survive cancer, their medication needs go beyond their cancer treatment. For veterans, VA physicians hope to bring more personalization to cancer survivorship plans for patients with pharmacogenetic testing. Read more on CAGPM website
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.