The NIH plans to spend $42 million over five years to fund clinical trials designed to evaluate whether and how the management of diseases such as high blood pressure, depression and chronic pain can be improved through genomic medicine.
The trials to be funded constitute the second phase of the Implementing Genomics in Practice (IGNITE) Network. IGNITE was established in 2013 to develop methods for incorporating genomic information into clinical care and explore the methods for effective implementation, diffusion, and sustainability in diverse clinical settings.
The NIH detailed two trials to be funded as part of the second phase of IGNITE, called IGNITE II.
The first trial will be designed to examine whether early access to patients’ genomic data can help with treatment of high blood pressure, hypertension and chronic kidney disease.
All three conditions are more common among people of African ancestry than European and Asian descent. Specific African populations have two common mutations in the apolipoprotein L1 (APOL1) gene that increase susceptibility to severe kidney disease by a factor of 10.
Researchers will compare whether medical intervention provided to those tested for the APOL1 variant immediately after recruitment, versus those tested three months later, will have subsequent benefits, the NIH said.
“Patients of African ancestry might experience better management of high blood pressure and improved prevention of kidney disease caused by high blood pressure,” Simona Volpi, Ph.D., program director of IGNITE pragmatic clinical trials, said in a statement. “Treatment of depression and/or pain in patients regardless of race or ethnicity may be more effective and have fewer side effects when using a genomic approach to prescribing drugs for these conditions.”
The second trial will be designed to focus on pain and depression. According to NIH, the study will seek to test whether patients with acute post-surgical pain, chronic pain, and depression have better clinical outcomes if pharmacogenomics guide opioid and antidepressant prescriptions.
Research teams at the University of Florida, Gainesville; the University of Indiana, Bloomington; Duke University, Durham, North Carolina; Vanderbilt University, Nashville, Tennessee; and the Icahn School of Medicine at Mount Sinai, New York; will carry out the clinical trials.
IGNITE II is intended to support a network of multi-site Clinical Groups (CGs) involving diverse settings and populations to conduct 2-3 pragmatic clinical trials of genomic medicine interventions. According to the NIH, the goals of these pragmatic clinical trials will be to:
- Measure the clinical utility and cost-effectiveness of genomic medicine interventions;
- Assess approaches for real-world application of genomic medicine in diverse clinical settings; and
- Produce generalizable knowledge on the types of genomic medicine interventions requiring randomized clinical trials and effective methods for conducting them.
IGNITE’s first phase, called IGNITE I, was a consortium of collaborative genomic medicine pilot demonstration projects designed to demonstrate the feasibility of, and develop methods for, incorporating an individual patient’s genomic findings into his or her clinical care.