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HHS Report Urges Personalized Medicine in CER

NEW YORK (GenomeWeb News) – A US Department of Health and Human Services group yesterday issued a report offering recommendations for using personalized medicine in comparative effectiveness studies.

The report by the Federal Coordinating Council for Comparative Effectiveness Research — which was created by the American Recovery and Reinvestment Act and is tasked with evaluating how to use stimulus funding for comparative effectiveness research — says that comparative effectiveness should "complement the trend in medicine to develop personalized medicine," and should use the ability to investigate drug and dosage effects at the sub-group level in ways that are difficult in randomized trials.

The ARRA stimulus package provided $1.1 billion for comparative effectiveness including $300 million to the Agency for Healthcare Research and Quality; $400 million for the National Institutes of Health; and $400 million for the Office of the Secretary of Health and Human Services.

In the report, the council argued that personalized medicine "aims to make medical care more precise and effective," and it appears to hold the promise of lowering costs. Increasing knowledge of how to use and understand patients' genomic profiles "will enable us both to use more effectively the therapies we have now and to identify significant areas where research and development of new products may be needed," according to the report.

The council wrote that pharmacogenomics "is expected to be a hallmark of this approach."

The group expects comparative effectiveness to be "an important partner in helping to bring about this new level of medical effectiveness, personalization, and innovation," while it also will be used to "identify which interventions and strategies work best on average."

"This essential patient centered research will help give patients and doctors more information so they can make the best decisions," HHS Secretary Kathleen Sebelius said in a statement accompanying the report.

The council also said that it has sought and collected statements from "hundreds of diverse stakeholders," which "influenced the entire report."

In the report, the council said stakeholders reported "support for the growth of personalized medicine," and some asked that some attention be paid to health disparities between racial and ethnic subgroups and that they be included in some study designs.

The comparative effectiveness council will issue its proposed plan for HHS at the end of July.

More information on the council and its report can be found here.