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 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.
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
- SGIM Annual Meeting
April 20-23, 2020
Join the Society of General Internal Medicine (SGIM) at the premier event for networking and knowledge in the field of academic GIM. The 2021 SGIM Annual Meeting will encompass the breadth and depth of General Internal Medicine, including health services research, medical education, advocacy, and exemplary clinical care.
- Genomic and Precision Medicine Forum – Matthew Engelhard, M.D., Ph.D.
Senior Research Associate, Department of Psychiatry & Behavioral Sciences
December 17, 2020
12 – 1 P.M.
- Genomic and Precision Medicine Forum – Ephraim Tsalik, M.D., Ph.D.
Associate Professor of Medicine
December 3, 2020
12 – 1 P.M.
- GUARDD-US Team Activates All Sites February 25, 2021
Congratulations to the Genetic testing to Understand and Address Renal Disease Disparities across the US (GUARDD-US) team for getting all sites activated approximately one month after reaching milestone of 1,000 patients enrolled.
- IGNITE Diversity & Inclusion Statement November 25, 2020
The IGNITE Network Leadership calls for Diversity and Inclusion in the conduct of research
We call on scientific and medical communities to acknowledge and work toward eliminating the injustices perpetuated through all forms of systemic racism and discrimination, both past and present, overt and covert. We condemn eugenic beliefs, policies, and practices. While ancestry has some genetic underpinnings, race is a social construct. Thus, we recognize the consequences of racism and bias on health, healthcare, and research.
To provide more equitable care ...
- Fellowship in Genomic Medicine Program Management November 6, 2020
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 ...
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.
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.