Using genomic variation to tailor therapeutic, preventative, and diagnostic decision-making is a potentially transformative approach to clinical care. However, uncertainty about clinical impact and economic value presents a critical barrier to broad adoption. The Integrated, Individualized, Intelligent Prescribing (I3P) Clinical Trials Network includes three clinically and sociodemographically diverse health systems to IGNITE 2: Metro General Hospital at Meharry Medical College, Sanford Health and Vanderbilt University Medical Center (VUMC). The Network will develop infrastructure to quickly recruit large, diverse patient populations, return results at the time of clinical indication, and provide health care providers with understandable, implementable guidance during the course of the trial.
The first aim will develop and implement infrastructure to efficiently conduct pragmatic clinical trials involving Genomic Medicine across the diverse settings within I3P.
The second aim proposes a randomized, pragmatic clinical trial of multiplexed pharmacogenomics testing across the IGNITE 2 Network to establish the clinical utility of panel testing. And finally, I3P will develop and implement an IGNITE 2 Network-wide capability to calculate Phenotype Risk Scores across health system populations to efficiently identify and intervene on patients likely to have a genomic diagnosis. All of the institutions within the I3P Network will leverage their strong record of collaboration within IGNITE 1 and other NIH funded consortia to accomplish these aims.

Public Health Relevance

The evidence base supporting the clinical and economic value of genetic testing is incomplete and an impediment to broader adoption of this technology. The Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trials Network will conduct pragmatic clinical trials as part of IGNITE 2 to test key research questions regarding the effectiveness of using genetic information to tailor prescribing, diagnosis, or preventative care. The I3P Network will also develop infrastructure and new capabilities to increase the efficiency and reach of any pragmatic clinical trial conducted within IGNITE 2.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HG010232-03
Application #
9968319
Study Section
Special Emphasis Panel (ZHG1)
Program Officer
Volpi, Simona
Project Start
2018-09-19
Project End
2023-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Type
DUNS #
079917897
City
Nashville
State
TN
Country
United States
Zip Code
37232