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Inadequate Health IT May Hold Up Era of Personalized Medicine, AHRQ Official Says

While some observers consider a lack of well-designed randomized trials as the primary impediment to advancing personalized medicine, the real bottleneck may be an ineffective health information technology system, a top official from the Agency for Healthcare Research and Quality said at a recent conference.
Carolyn Clancy, director of the AHRQ, noted that an integrated health IT system would help capture missing data that is currently holding up validation and adoption of pharmacogenomic tests.
“It’s pretty clear when you look at [AHRQ’s] systematic reviews that we have a lot to learn about the impact of these tests on treatment decisions and outcomes,” Clancy said during a conference hosted by the Personalized Medicine Coalition in Washington, DC, Sept. 18-19.
“I think [HHS] Secretary [Michael Leavitt] said it very clearly that randomized trials are one way to get there, but we think that we haven’t begun to push the frontier of using observational and other methods so that we can actually learn from the care delivery system itself,” Clancy said. She quoted US Food and Drug Administration Commissioner Andrew von Eschenbach, who said at the Food and Drug Law Institute Annual Conference last April that the “healthcare delivery system can be a platform for discovery.” 
According to Clancy, AHRQ is engaged in a number of projects that might advance the US health information technology infrastructure toward a more interoperable system in which genomic data can be readily shared. The agency “will be launching a couple of contracts to begin to scope out what it is going to take to create this distributed network,” she said. “We’re still in negotiations, so all I can tell you is watch for an announcement in the near future.”
On the clinical evidence side, AHRQ has been working on the Centers for Disease Control’s Evaluation of Genomic Applications in Practice and Prevention pilot project to evaluate and make recommendations regarding the use of gene-based tests. The agency in January released its review of gene-based tests to personalize the dose of selective serotonin reuptake inhibitors for non-psychotic depression and found “insufficient evidence” to determine if such assays help make treatment decisions [see PGx Reporter 01-10-2007].
Previously, the agency evaluated tests for single gene products, genetic variations affecting risk of ovarian cancer, gene expression, and proteomics for CA-125 and BRCA1/2 and determined that these tests have not shown clinical value [see PGx Reporter 11-08-06].
The much-anticipated “era of personalized medicine” has been slow to come and pharmacogenetic tests have seen a sluggish adoption rate. Industry observers have blamed this perceived delay on various factors: poor reimbursement, the lack of Rx/Dx partnerships, the dearth of outcomes data, and the need for physician education.
However, during a meeting of the American Health Information Community in November last year, Leavitt seemed to think that information technology might be the infrastructural missing link that has been holding personalized medicine at bay. He said during that meeting that AHIC would create a workgroup to address IT and other issues related to personalized healthcare, including genetic testing and genomic data standards [see PGx Reporter 11-01-2006].

For its part, AHRQ is currently promoting health IT through various state and regional projects. It has also developed a network of 13 research centers, under a collaboration called Developing Evidence to Inform Decisions about Effectiveness, or DEcIDE, to carry out accelerated studies to fill knowledge gaps about treatment effectiveness.
DEcIDE “consists right now of a network of research partners who all have access to clinical electronic information in a variety of forms,” Clancy said. The DEcIDE centers are analyzing anonymous data from more than 50 million patients available through insurers, health plans, and other partner organizations to investigate use patterns, as well as the benefits and risks of medications and other therapies.
Currently, through the DEcIDE Network, AHRQ is “working with the CDC to review existing databases focused on utilization and outcomes of gene-based tests and therapies,” Clancy said.  
Another area of focus in 2008 at AHRQ is the “Partnership for Effective Health Care” project, which “takes advantage of the investments in health IT that many healthcare organizations have made.” According to Clancy, the project will begin integrating health records across partner organizations on Oct. 1.
Ultimately, AHRQ will “launch a public-private partnership with a number of these organizations with a strong focus on emerging [diagnostics and therapeutics] that we would call personalized healthcare,” Clancy said.
“No organization, including CMS, can take this on on their own. They really do need to work with others, but the front-end work is going to be building a lot of infrastructure,” she added.

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