Indiana University School of Medicine and the Indiana University Institute for Personalized Medicine in collaboration with the Eskenazi Health System conducted a study to evaluate the economic and clinical outcomes associated with embedding a pharmacogenomics program in a system that serves as a health care safety-net in Indianapolis, Indiana.
Paul R. Dexter, M.D.
Indiana University School of Medicine
Associate Professor of Clinical Medicine
Research Scientist, Regenstrief Institute
Chief Medical Information Officer, Eskenazi Health
Todd Skaar, Ph.D.
Indiana University School of Medicine
Associate Professor of Medicine
The late Dave Flockhart, M.D., Ph.D. (1952-2015)
Former Chief of the Division of Clinical Pharmacology
The Harry and Edith Gladstein Chair in Cancer Pharmacogenomics
A guiding force in the work of the INGENIOUS project and the IGNITE Network as the former Chair of the IGNITE Steering Committee
The Eskenazi Health System handles over 1.2 million outpatient visits a year at its hospital and network of 10 community health centers. There are over 990,000 outpatient visits and 15,000 adult admissions annually, and the payor mix includes 45 percent uninsured, 26 percent Medicaid and 18 percent Medicare patients. This health care system has more than 40 years of experience in digital medical record implementation and a proven track record of innovation in medical informatics that is based in the Regenstrief Institute.
The goal of Personalized Medicine (PM) is to implement advances in biomarker pharmacology, molecular diagnostics and genomics to improve the health of patients afflicted by a wide range of medical conditions. Dramatic advances in genomics have identified numerous disease/therapeutic associations now placing this goal within sight. For the full benefits of personalized genomic medicine to be realized, it is now critical that progress made on a small scale be extended. The fruits of outstanding scientific discovery are often enjoyed by a small number of academic medical centers but are not scalable, and therefore not available to the masses of patients found in larger health care systems. In addition, such advances often bypass underserved populations, resulting in significant inequalities of care.
- To test the hypothesis that a CLIA certified genotyping targeted at 24 widely used drugs is associated with significant reductions in hospital and outpatient economic costs incurred over one year.
- To test whether pharmacogenetic testing is associated with significant improvements in clinical outcomes over one year.
The INGENIOUS trial enrolled 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who were followed, but not tested. The study was prospective since practice patterns change, and retrospective designs cannot be used to assess the impact of a prospective change.
It was randomized between an intervention arm and one that receives no intervention in order that a genotyped group could be compared with one in which undisturbed, routine clinical care was carried out in patients taking the same drugs. Both arms were followed for a year. Subjects were enrolled starting at six months into the funding period; enrollment lasted for two years, so that the last person enrolled would be at 2.5 years, and follow-up was completed at 3.5 years, allowing six months for analysis at the end of the study.
A pharmacogenetic test, involving 51 SNPs in 16 genes was carried out at the beginning of the study in patients in the testing arm upon prompting by an index medication: one of 24 selected was supported by validated guidelines.
- Paul R. Dexter, M.D. – PI
- Todd Skaar, Ph.D. – PI
- Samir K. Gupta, M.D. – Co-Investigator
- David M. Haas, M.D. – Co-Investigator
- Raj Vuppalanchi, M.D. – Co-Investigator
- Gail Vance, M.D. – Co-Investigator
- Rolf Kreutz, M.D. – Co-Investigator
- Thomas Callaghan, M.D., Ph.D. – Co-Investigator
- Brian Decker, M.D., PharmD – Co-Investigator
- Marc Rosenman, M.D. – Co-Investigator
- Desta Zeruesenay, Ph.D. – Co-Investigator
- Lang Li, Ph.D. – Co-Investigator
- Vicky Pratt, Ph.D., FACMG – Co-Investigator
- Ann Holmes, Ph.D. – Co-Investigator
- Kenneth Levy, Ph.D., MBA – Program Manager