GMKBAttendees to a January 2019 DCRI Think Tank outlined recommendations for optimizing pragmatic clinical trials and weighing risks and benefits of innovative trial designs.
GUARDD-US Enrolls First Patient
IGNITE hit a major milestone on July 10, 2020: The University of Florida randomized the first patient in to the GUARDD-US pragmatic clinical trial.
Genetic testing to Understand Renal Disease Disparities across the US (GUARDD-US) will investigate the results of apolipoprotein L1 (APOL1) genotyping in an African American population.
The primary outcome is systolic blood pressure (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. The team will re-randomize APOL1 negative patients to a genotype-guided approach to anti-hypertensive therapy versus usual care and compare three-month SBP.
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.
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.
Read the announcement from NIH Director Francis Collins, M.D., Ph.D.
IGNITE blazes the way for genomic medicine
Getting diagnosed with a disease can be scary. Health providers work to find the right treatment plan based on the current standard of care guidelines. But what if in addition to the current evidence, doctors could also factor in each patient’s unique genetic makeup to help them diagnose more quickly and accurately, create a tailored treatment plan, or better yet, learn which patients are at a higher risk for developing specific diseases and employ methods for prevention or earlier detection? That’s the hope of genomic medicine, but researchers and clinicians are still gathering more evidence of its effectiveness before it can be widely implemented.
The IGNITE Network is looking to provide some of that evidence. The Network is comprised of a coordinating center and five multi-site clinical groups from Duke, Mt. Sinai, Vanderbilt, University of Indiana and University of Florida.
In order to provide the evidence that this type of practice will improve patient outcomes, IGNITE is conducting two large, network-wide genomic medicine pragmatic clinical trials (PCTs). These PCTs are focused around genetic risks for common chronic diseases and pharmacogenomics. PCTs are different than randomized controlled trials, or RCTs, which are great for studying the effectiveness of a treatment, but PCTs allow for bigger, more efficient clinical trials and help researchers and clinicians understand what to expect in real-world clinical settings.
Genetic testing to Understand Renal Disease Disparities across the U.S. (GUARDD-US) is a PCT 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. The team will re-randomize APOL1 negative patients to a genotype-guided approach to anti-hypertensive therapy versus usual care and compare three-month SBP.
A Depression and Opioid Pragmatic Trial in Pharmacogenomics (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.
Both GUARD-US and ADOPT PGx teams will begin recruiting people for the PCTs in mid to late 2020.
The IGNITE Network has the potential to drastically change the face of healthcare. As results from the PCTS come in, clinicians all over the world may be able to see the clinical utility of genomic medicine for both risk assessment and disease treatment.
Affiliate network members as force amplifiers of genomic medicine research
Future Medicine — The Implementing GeNomics In pracTicE (IGNITE) Network is an NIH-funded network dedicated to advancing the implementation of genomics in healthcare.
Pharmacogenomics competencies in pharmacy practice: A blueprint for change
Journal of the American Pharmacists Association – The emerging use of genomic data to inform medication therapy populates the medical literature and provides evidence for guidelines in the prescribing information for many medications.
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.
Andrea Ramirez to present at the AMIA 2019 Annual Symposium
Dr. Andrea H. Ramirez will present her 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. Her research was selected out of a record number of submissions to AMIA this year — over 1,200 across all categories!
Dr. Ramirez is an Assistant Professor of Medicine in the Division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center. 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.