NIH is funding clinical trials that will improve chronic disease management with genomic interventions.
The National Institutes of Health (NIH) will fund clinical trials to assess the benefits, applicability, and efficacy of applying genomic medicine to chronic disease management.
The trials are part of the second phase of the Implementing Genomics in Practice (IGNITE) Network with a total investment of $42 million over five years.
The first clinical trial will examine whether early access to patients’ genomic data can help with treatment of high blood pressure, hypertension, and chronic kidney disease among certain populations.
Both hypertension and blood pressure exacerbate end-stage kidney disease, and all three diseases are more common among people of African ancestry. Specific Asian populations also have two common mutations in a certain gene, the apolipoprotein L1 (APOL1) gene, that increase susceptibility to severe kidney disease by a factor of 10.
In this first clinical trial, the team will test one group of participants for the APOL1 variant immediately after recruitment and test a second group after three months. The researchers will then compare the benefits of medical treatment in the two groups.
In the second trial, researchers will focus on depression and pain. Because there are few clinically useful predictors for whether a depression treatment will be successful, patients often struggle to find therapies that work for them. The study will aim to test whether patients with acute post-surgical pain, chronic pain, and depression have better outcomes if researchers consider a patient’s genetic makeup before prescribing opioids and antidepressants.
Both studies will add to the first phase of the IGNITE Network, which was funded by the National Human Genome Research Institute in 2013. IGNITE’s first phase focused on challenges and possible solutions to incorporating genomic data into the EHR.
In addition to the IGNITE trials, NIH is leading the National Cancer Institute’s Molecular Analysis for Therapy Choice (NCI-MATCH) trial, the largest precision medicine trial of its kind. Researchers are using patient genomic data to develop effective treatments for rare forms of cancer.
In a recent report, NCI researchers discussed the latest findings from NCI-MATCH, revealing that a particular drug combination was a promising treatment for certain cancer types.
“NCI-MATCH is an ongoing and dynamic trial,” Alice Chen, MD, a medical oncologist at the NCI, head of the NCI’s Early Clinical Trials Development Program, and NCI study chair for the overall NCI-MATCH trial, said at the time.
“Its signal-finding approach will likely influence how cancer clinical trials are designed and conducted in the future, as treatments that show promise may advance to more definitive studies.”
With these new clinical trials, NIH expects to evaluate the clinical utility and cost effectiveness of genomic medicine for chronic disease. Researchers may find real-world applications for genomics across clinical settings, which could improve care for particular populations living with a chronic condition.
“Patients of African ancestry might experience better management of high blood pressure and improved prevention of kidney disease caused by high blood pressure,” said Simona Volpi, PhD, program director of IGNITE pragmatic clinical trials.
“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.”
Date: June 12, 2019
Source: Health IT Analytics