Collaboration explores ways to personalize medicine

May 21, 2015

In cooperation with Eskenazi Health, the Indiana Institute for Personalized Medicine, the IU School of Medicine and the Regenstrief Institute are evaluating how genetics impact the responsiveness and efficacy of certain drugs. It is believed to be the first study of its kind to examine both the economic and clinical value of implementing personalized medicine.

Lisa Harris, M.D. | Photo By Eskenazi Health

Most medical treatments in use across the country today have been designed for the "average patient." As a result of this one-size-fits-all approach, treatments can be very successful for some patients but not for others. Taking into account individual differences in people's genes, environments and lifestyles, personalized medicine gives clinicians tools to better understand the complex mechanisms underlying a patient's health, disease or condition and to better predict which treatments will be most effective. 

The groundbreaking study, launched at Eskenazi Health last month, will examine whether pharmacogenetic testing -- the study of the role of genetics in drug response -- is associated with improvements in clinical outcomes. In other words, the study will review whether information about a patient's genetic composition can be used to help guide a physician in determining what medications might be most effective for treating conditions such as hypertension, heart disease and diabetes. The study will target 33 drugs to also determine if there is significant association with a reduction in hospital and outpatient costs incurred over one year.

"For more than a century, our partnership with the Indiana University School of Medicine has helped to inform and advance how care is delivered across the world," said Lisa Harris, M.D., chief executive officer of Eskenazi Health. "The opportunity to now be on the leading edge of personalized medicine, with the precision that allows physicians and patients to more rapidly establish effective treatment and control of chronic conditions, is a direct result of our continued collaborative efforts to bring the best that science has to bear in improving care."

Lawmakers in Washington, D.C., are expected to consider a funding proposal from the White House later this year to invest millions of dollars in personalized medicine through research and translational sciences. 

The two-year study at Eskenazi Health's main campus will enroll a total of 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed, but not tested. 

David Flockhart, M.D., Ph.D. | Photo By Indiana Institute for Personalized Medicine

Patients will be followed for one year. Eskenazi Health patients from both outpatient and inpatient areas of the health system as well as emergency department patients may be asked to participate if they are prescribed one of the 33 medications identified. Patients selected for the testing arm will receive a blood draw that will evaluate the most common type of genetic variations that exist within 16 specific genes. The blood draw is the only interaction patients will have with the study unless a second medication is prescribed during the course of the study period. David Flockhart, M.D., Ph.D., director of the Indiana Institute for Personalized Medicine and Paul Dexter, M.D., chief medical information officer at Eskenazi Health and Regenstrief scientist, are the study's principal investigators.

According to Dr. Flockhart, "Scientists will test the utility of this approach in a community-based setting, and in rural, underserved and economically disadvantaged populations and we need to figure out not only whether using genomics in the clinic can be helpful to patients, but also if it will be cost effective."

The study will utilize the Regenstrief Institute's cutting-edge clinical decision support platform and vast informatics knowledge.

The Indiana Institute for Personalized Medicine explores how genetic information and environmental exposure affect each person's risk for developing certain diseases and their response to medication. The institute examines how personalized medicine may be translated in clinical settings to advance the practice, delivery and economics of health care.

The study, known as INGenious (Indiana Genomics Implementation: An Opportunity for the Under Served), is supported by the National Institutes of Health and is one of three studies that has been included in a pilot program that totals more than $11 million in grant funding. Known as the Implementing Genomics in Practice program, the three studies are administered by the National Human Genome Research Institute, part of NIH.