Originally published Feb. 7.
By Turna Ray
Oracle and the non-profit Wisconsin-based healthcare provider Aurora Health Care have teamed up to conduct clinical trials faster using electronic medical records, data mining, and biomarkers.
As one of the largest healthcare systems in the Midwest, Aurora currently serves more than two million people whose medical information is stored in electronic health records. The healthcare provider believes that Oracle can provide the informatics muscle to mine patient EHRs in order to "conduct clinical trials [in] more advanced ways, which will have better patient-centered outcomes," Randall Lambrecht, Aurora's VP of research and academic relations, told PGx Reporter.
Aurora has been ramping up its capabilities to delve into outcomes research for genomically guided treatments. As reported by PGx Reporter sister publication BioInform, two years ago Aurora launched an automated biorepository at St. Luke Medical Center, called the Open-Source Robotic Biorepository & Informatics Technology, or ORBIT, which integrates patient samples with de-identified health records (BI 04/24/09).
Aurora has now tapped Oracle to develop a system under which researchers could mine the health records associated with ORBIT to select patients with specific criteria, such as poor response to a given therapy, who could serve as clinical trial cohorts.
Currently, ORBIT contains between 81,000 and 82,000 anonymized patient samples, and Aurora hopes to bring the number to 500,000 over the next three to five years. Aurora currently has more than 600 active clinical research protocols and more than 400 studies underway.
"The collaboration with Oracle is designed to help us manage our data since they are experts at data informatics [and] analytics," Lambrecht said. According to Aurora, the project will specifically focus on "the secondary use of clinical data for improving processes for clinical studies including comparative effectiveness research, safety monitoring, and long-term observational studies."
While Aurora's long-term plans include research using pharmacogenomic strategies, for the time being, it will use genomics primarily for biomarker discovery work.
Pharmacogenetics research will probably not be possible right away, Lambrecht said. However, "Aurora has made investments in the development of a biorepository over the past five-plus years in anticipation that genomic data will play an important role in prevention and disease intervention," he noted. "We've already begun conducting in-house studies that look at genetic variations in certain disease types as well as [begun selecting] biomarkers for diagnostic purposes."
Preliminary areas of research that Aurora is focusing on include cardiovascular diseases, cancer, women's health conditions, and neurosciences, as well as chronic diseases, such as diabetes, that impact the population Aurora serves.
Studies that evaluate the safety and effectiveness of treatments for genomically defined subpopulations will also be part of Aurora's efforts, under the broader umbrella of comparative effectiveness research.
"CER sounds like a simple comparison of therapies where one is always going to outperform another," Lambrecht said. "I'd rather think of [CER] as patient-centered outcomes research."
As the US government has provided more funding for CER and has set up an independent institute for conducting this type of research, personalized medicine advocates have worried that CER will be used to parse through the clinical and cost effectiveness of treatments for the broader population, instead of using genomic strategies to figure out the best medicine for those likely to benefit. However, the fact that there are genomics researchers and personalized medicine advocates on the Patient-Centered Outcomes Research Institute's board of governors has led some observers to believe that genomic medicine won't be sacrificed for one-size-fits-all types of drugs.
"Truth is, an effective therapy depends on the individual, so multiple therapies may be needed, which is the exactly the point with personalized medicine — [to identify the] treatment [or] therapy designed for the individual," Lambrecht said. "We hope to get to a point of better predicting which therapy or treatment a patient will respond to best, and perhaps genomics information together with clinical data will help us achieve this goal. If clinical trials can be strategically designed, they will be safer, cheaper, more meaningful, and of higher quality."
Since CER studies, particularly those using PGx strategies, require a hefty investment, long time frames, and large patient cohorts, several seemingly disparate players in the healthcare industry have recently pooled their resources to enable these types of comparative projects.
For example, earlier this month, AstraZeneca and HealthCore, the research arm of the national insurer WellPoint, announced an agreement to conduct CER to investigative the clinical- and cost-effectiveness of treatments for chronic illnesses. HealthCore runs a database containing medical, pharmacy, and laboratory results from 36 million enrollees in local Blue Cross and/or Blue Shield plans in 16 states.
It seems that genomics will play a part in AstraZeneca and HealthCore's CER efforts. "In an era of advancing medical knowledge in pharmacogenomics and the dawn of personalized medicine, it will be increasingly important to understand why drugs are more effective in certain individuals," WellPoint Chief Medical Officer Sam Nussbaum said in a statement. "While we want to focus on prevention, the mainstay of treatment of chronic illness is the effective use of drug therapy to reduce the consequences of these illnesses."
James Blasetto, AstraZeneca's VP of US strategic development, added that the drug giant and HealthCore may invite other public and private organizations in their CER efforts.
Deals like the one between Oracle and Aurora, and AstraZeneca and WellPoint, signal growing interest among healthcare providers and payors to use CER to contain costs and the emerging realization that individualized care may be the best way to lower unnecessary spending.
Certainly, at a conference last year on CER and personalized healthcare, Lee Newcomer, senior VP of oncology at UnitedHealthcare, and Barry Straube, chief medical officer and director of the Centers for Medicare & Medicaid Services' Office of Clinical Standards and Quality, both expressed support for using CER to drive use of treatments that are most effective and also save money (PGx Reporter 12/08/10).
Their comments also showed that for the most part payors are still of the opinion that personalized medicine lacks the evidentiary support to justify broad coverage. However, payors do see CER as a way to gather data on whether to reimburse for certain genomically guided medicines.
For Aurora, its collaboration with Oracle may also help attract the attention of drug and diagnostic players who want to gather clinical evidence on Rx/Dx combination products.
"We always want to work with pharma and biotech companies to attract the best clinical trials with the newest diagnostics [and] treatment therapies … for our patients," Lambrecht said. "If we can efficiently provide a profile of potential patient study populations within Aurora, and work with sponsors more effectively, we hope they will see Aurora as a willing partner in their drug development planning."
Through its recently announced plans to create the National Center for Advancing Translational Science, the National Institutes of Health has also gotten involved in conducting translational research to advance treatments for neglected or rare diseases using molecular strategies. "Hopefully we will be well positioned to be a part of that effort," Lambrecht said.
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