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Page 7 of 77 FCCCE Report to President & Congress 6/30/09

Early in the process, the Federal Coordinating Council for Comparative Effectiveness Research (FCCCER) set the following objectives consistent with ARRA (stimulus bill):

1.Develop a definition, establish prioritization criteria, create a strategic framework, and identify priorities that lay the foundation for CER.
2.Foster optimum coordination of comparative effectiveness research conducted or supported by relevant Federal departments.
3.Formulate recommendations for investing the $400 million appropriated to the HHS Office of Secretary as part of this Report to Congress.

Definition and Criteria

The Council first established a definition, building on previous definitions, for comparative effectiveness research:
Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

•To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
•Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
•This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.

The Council needed explicit criteria to make recommendations for priorities. Therefore, the Council’s second step was to establish minimum threshold criteria that must be met and prioritization criteria.

Minimum Threshold Criteria (i.e. must meet these to be considered):

•Included within statutory limits of Recovery Act and the Council’s definition of CER
Potential to inform decision-making by patients, clinicians, or other stakeholders
Responsiveness to expressed needs of patients, clinicians, or other stakeholders
•Feasibility of research topic (including time necessary for research)

The prioritization criteria for scientifically meritorious research and investments are:
•Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm)
•Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research
Uncertainty within the clinical and public health communities regarding management decisions and variability in practice
•Addresses need or gap unlikely to be addressed through other organizations
•Potential for multiplicative effect (e.g. lays foundation for future CER such as data infrastructure and methods development and training, or generates additional investment outside government)

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