Applying Genomics to Clinical Trials

NIH https://www.nih.gov is going to fund clinical trials to assess the benefits, applicability, and efficacy for applying genomic medicine interventions to improve the management of diseases such as high blood pressure, depression, and chronic pain.

The trials are part of the second phase of the Implementing Genomics in Practice (IGNITE) Network https://ignite-genomics.org funded in 2013 by the National Human Genome Research Institute https://www.genome.gov. The Network is focused on incorporating genomic information into EHRs and aims to develop and facilitate the application of genomics to diverse clinical care settings.

NIH plans to invest $42 million over five years, pending the availability of funds and begin trials in 2020. The first trial will examine whether early access to patients’ genomic data can help treat high blood pressure, hypertension, and chronic kidney disease. Both hypertension and high blood pressure exacerbate end-stage kidney diseases. 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 APOL1 gene that may 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 second trial will focus on pain and depression. To combat these issues, 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.