GMKBThe 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 are intricately involved in all aspects of IGNITE design and operation.
In order to provide 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 disseminates the methods and best practices its members develop in order to advance genomic implementation in healthcare. One outlet for public distribution is the IGNITE 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 behavioral 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.
ADOPT-PGx
A Depression and Opioid Pragmatic Trial in Pharmacogenomics
Lead Sites: University of Florida Health, Indiana University, and Vanderbilt University
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.
GUARDD-US
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
News
- GUARDD-US Team Surpasses Enrollment Goal December 15, 2023
The GUARDD-US study aims to determine the impact of disclosing genetic of kidney failure among adults with African ancestry on blood pressure. The GUARDD-US study team celebrated surpassing their enrollment goal on September 30, 2023 after enrolling 6,754 participants. The last participant is expected to complete the follow-up period for the trial by May 2024.
The study is a prospective, multicenter, unblinded, two-arm randomized pragmatic clinical trial investigating the impact of apolipoprotein L1 (APOL1) genotyping in patients with self-reported African ancestry ...
- ADOPT-PGx Team Reaches End-of-Enrollment Milestone December 15, 2023
ADOPT-PGx recently celebrated reaching its participant enrollment milestone in September 2023 following the enrollment of 4,111 total participants. The last participant should complete the follow-up period for the trial by April 2024.
The primary goal of the study is to reduce depression symptoms and improve pain control in participants who are expected to process anti-depressant or pain medications faster or slower than normal as indicated by pharmacogenetic testing. Secondary goals include safety endpoints, changes in overall well-being, and differences in healthcare ...
- CCPM’s Biobank unearths disease risk and pinpoints problems with medications November 5, 2023
The biobank at the Colorado Center for Personalized Medicine (CCPM), a partnership between UC Health and the University of Colorado Anschutz Medical Campus, uses genetic data to identify specific genetic variants that could increase the risk of health problems, such as cancer or heart disease, as well as issues with how patients process a variety of medications.
A patient’s biobank results give them the opportunity to work with their providers to learn about their risks, make lifestyle changes to aid in ...
Events
PRECISE-IHCC Conference 2024
PRECISE-IHCC Conference 2024 | From Cohorts to Clinics: The New Landscape of Global Healthcare August 21 – 23 | Singapore Jointly organized by Precision Health Research, Singapore (PRECISE) and the
August 21 - August 23
What is the IGNITE TOOLBOX?
The IGNITE 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.
Locations
The network is comprised of five research sites:
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 to learn more about genomics and how to best implement into healthcare.