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The American Recovery and Reinvestment Act of 2009 and Comparative Effectiveness Research

By: Dr. Michael Lauer

Wednesday, September 30, 2009

Dr. LauerIn the American Recovery and Reinvestment Act of 2009 (ARRA), Congress appropriated $1.1 billion for comparative effectiveness research, or CER, with $400 million allocated to the NIH.  To help ensure that the government aligns its priorities with national needs, the legislation created a Federal Coordinating Council (FCC) of senior federal officials who were charged to inventory and articulate major gaps in federal CER efforts.  The FCC was also asked to make recommendations to the Secretary of HHS about how best to spend the Department’s $400 million allocation.  The FCC members included Dr. Betsy Nabel, Director of the NHLBI; Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality; Dr. Joel Kupersmith, a cardiologist who is the Chief Research and Development Officer for the Veterans Administration; and Dr. Ezekiel Emanuel, Chair of the NIH Clinical Center Department of Bioethics.

The FCC issued its report on June 30; it also published a Perspective in the New England Journal of Medicine.  The FCC noted that there are already extensive CER research efforts and assets supported by the Federal government, and that the NIH is “the single largest sponsor of primary comparative effectiveness research.”  The report also noted that there are a number of major gaps, including lack of coordination, many unanswered patient-centered questions, inadequate human and scientific capital, limited training opportunities, fragmented data infrastructures with inadequate longitudinal outcomes information, and limited emphasis on research involving priority populations and sub-groups and non-pharmacological interventions. 

To address these gaps, the FCC suggested a framework (Figure) by which future government CER could be considered.   Investment priorities include research, human and scientific capital, data infrastructure, and dissemination and translation.  Themes that cut across all these investment priorities include populations, conditions, and interventions.  The FCC report recommended that as a primary priority, the Secretary of HHS should invest in building, supporting, and coordinating the CER data infrastructure.

As Drs. Conway and Clancy write in their Perspective essay, the ARRA investment in CER provides the government and society with a unique opportunity to use the tools of science to improve the quality of health care and health for all Americans.  In future issues of this column, we will highlight the NHLBI-funded ARRA CER projects that directly address the gaps identified by the FCC report. 

Distribution of the Recommended Research Priorities By Primary and Secondary Research Areas for Comparative-Effectiveness Research

Source: “Recommended High Level OS Investment Priorities,” Courtesy of the Federal Coordinating Council for Comparative Effectiveness Research, Report to the President and the Congress, June 30, 2009, Figure 3, Initial National Priorities for Comparative Effectiveness Research, 2009.

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