NEW YORK (GenomeWeb) — The National Institutes of Health announced today plans for two clinical studies that will investigate the benefits of genomic medicine in treating a range of diseases including kidney disease and depression.
The trials — which will be run by researchers at the University of Florida; the University of Indiana, Bloomington; Duke University; Vanderbilt University; and Mount Sinai's Icahn School of Medicine — are part of the second phase of the NIH's Implementing Genomics in Practice (IGNITE) program, which is slated to receive $42 million in funding over 5 years.
According to the NIH, the first trial will focus on mutations in the apolipoprotein L1 gene, which are common in African populations and associated with a greater susceptibility to severe kidney disease. Investigators will examine whether immediately testing trial participants for these variants — and providing medical intervention to those who test positive — offers a benefit over testing three months after recruitment.
The second study will test whether people with acute post-surgical pain, chronic pain, and depression have better clinical outcomes if pharmacogenomics is used to guide their opioid and antidepressant prescriptions.
The trials are set to begin in 2020.
"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, program director of IGNITE's pragmatic clinical trials (PCT), 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 first phase of IGNITE, which launched in 2013, aimed at developing new methods for implementing genomic medicine in diverse clinical settings outside of specialized care and disseminating its findings to the genomic medicine community. The second part is building off this work with a network of groups that will run PCTs of genomic medicine interventions previously demonstrated to be feasible and of potential value in clinical care.
In 2017, the NIH said it set aside $2.6 million in initial funding for the PCTs.