Project Summary The promise of genomic medicine to transform healthcare and improve health will not be fully realized until discoveries become relevant to and available for use by diverse populations and their clinicians. As part of the IGNITE II network, we are implementing two prospective randomized pragmatic genotype-guided clinical trials (GUARDD-US and ADOPT-PGx) to determine the impact of implementing genetic testing on hypertension, depression, and pain therapies. This administrative supplement request is to extend the implementation timeline for these two pragmatic clinical trials by 24 month to allow for completion of: ADOPT PGx recruitment and study follow-ups, GUARDD-US follow-ups, data analysis, writing up of study results and closeout of all study activities.We expect the successful results from this clinical trial will provide critical evidence needed to drive the implementation of genomic medicine across broad demographics of patient populations.

Project Narrative The Mount Sinai Clinical Group (MS CG) is requesting a 24-month extension with funds to complete the ongoing IGNITE Network pragmatic clinical trials, GUARDD-US and ADOPT-PGx. Additional time and funding are needed due to unanticipated network-wide delays in launching each trial and shutdowns due to COVID-19. Additionally, this administrative request includes funding to support the MS CG for leading analysis and publication costs for 5 secondary manuscripts.