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IGNITE Pragmatic Clinical Trials Network Trial Results

Friday, May 30, 2025
3:00 PM - 4:00 PM East Coast USA Time
Location: Woodrow Wilson

Session Description

The IGNITE Pragmatic Clinical Trials Network is a clinical trials network funded by NIH’s National Human Genome Research Institute to conduct pragmatic randomized controlled trials (pRCT) of clinical implementation of genomic medicine and its associated clinical outcomes. The network has just completed these studies, and the results of the trials will be presented in a public oral format for the first time at this session. All studies randomized patients to genotype-guided or usual care approaches, with genotype provided in the usual care arm at the end of their participation. The trials include: GUARDD-US, which tested APOL1 guided management of hypertension in 6,754 individuals of African ancestry. A portion of the study participants also participated in a pharmacogenetic substudy that tested YEATS4 and NAT2 to guide thiazides and hydralazine. The other three pRCTs within IGNITE, known collectively as A Depression and Opioid Pragmatic Trial of Pharmacogenetics (ADOPT-PGx), were conducted in parallel. The ADOPT-PGx pRCTs recruited patients with a clinical indication for pharmacogenetic testing and measured patient reported outcomes for pain or depression. All ADOPT-PGx trials included testing of CYP2D6, where the phenotype was defined by CYP2D6 genotype and CYP2D6 strong and moderate drug interactions. These included a study of CYP2D6-guided opioid therapy in the setting of acute post-surgical pain (n=1,602), a study of CYP2D6 guided opioid therapy in poorly controlled chronic pain (n=1,048), and CPY2C19 and CYP2D6 guided antidepressant therapy (n=1,461).

Learning Objectives

  1. Describe strategies for implementing and testing biomarker-driven personalized therapy approaches through pragmatic trial designs.
  2. Discuss the data resulting from a pragmatic trial of APOL1-guided hypertension management.
  3. Discuss clinical outcomes associated with pharmacogenetic implementation in pain and depression.