IGNITE Cost Extension- Year 7

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Principal Investigator: Lori Ann Orlando
Organization: DUKE UNIVERSITY
Fiscal Year: 2024
Award: $345,120
Funding agency: National Human Genome Research Institute

This cost extension for the IGNITE network was requested by NHGRI program office in order to
complete the activities for the network trials GUARDD and ADOPT-PGX as well as the follow-on
network activities. The delays in the trials for GUARDD and ADOPT-PGX were multifactorial
and were greatly influenced by the COVID pandemic. In addition, some trial specific challenges
led to delays: the length of time to develop protocols and processes, the complexity of the sIRB
and reliance agreements among so many sites, procedural differences at each site, adding
additional recruiting health systems mid-way, and the need to increase enrollment targets to
account for adjustments to the power analysis. In this second year of the cost extension we will
be completing study closeout activities, secondary analyses for papers, and continuing to
participate in the network.

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