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Grand Opportunities in Comparative Effectiveness Research.

The NIH has received new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"). Of these funds, $400million has been designated to fund comparative effectiveness research. For the purposes of this RFA, comparative effectiveness research (CER) involves "the conduct, support, or synthesis of research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions. CER uses a variety of data sources and methodologies, including patient registries, clinical data networks, pragmatic clinical trials, decision analyses, and meta-analyses to produce rigorous and valid evaluations." The program, titled Research and Research Infrastructure "Grand Opportunities" or "GO" grants is one of a number of NIH initiatives related to the Recovery Act, all of which are listed at: It will support projects, including comparative effectivenss projects, that address large, specific biomedical and biobehavioral research endeavors that will benefit from significant 2-year funds without the expectation of continued NIH funding beyond two years. Comparative effectiveness research supported by the "GO" grants program should provide a high short-term return and offer a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

Comparative Effectiveness

For many acute and chronic neurological conditions, clinical practitioners are faced with a number of management options, including multiple drugs, devices, procedures, behavioral interventions, and implementation methods. Clinical practice may vary widely and there is a lack of systematic evidence regarding how different approaches to prevention and treatment compare with one another. Comparative effectiveness research attempts to compare rigorously the effects of different available options on clinical outcomes, in order to inform clinical practitioners about how to provide the right services for the right patient at the right time in the right setting. While comparative effectiveness research can be highly informative, it also presents numerous methodological and logistical challenges.

CER studies typically focus on comparing the impact of different options on comprehensive health outcomes, including patient mortality, morbidity, quality of life, and performance of the health system. The overarching goal is to provide better evidence so that individual patients will receive effective, efficient, patient-centered care."

This funding opportunity will support two-year efforts that will substantially accelerate comparative effectiveness research, advance methods development and priority setting, and develop and identify infrastructure to support the conduct of comparative effectiveness research. Illustrative examples of responsive projects include those that target neurological diseases and those that:

  • Plan initiatives (including feasibility and vanguard studies) to prepare for the launch of large-scale pragmatic comparative effectiveness trials of interventions for neurological conditions of substantial public health importance.
  • Identify and develop methods for utilization of databases and research consortia that can address comparative effectiveness questions for diagnosis, prevention or treatment of neurological conditions. For example, establishing or enhancing user-friendly registries that can be queried and used to identify subjects, enroll them rapidly, and then follow them over time for large-scale trials or other CER studies.
  • Develop and/or advance analytic techniques and quantitative methods for analyzing comparative effectiveness clinical trials.
  • Design and evaluate complex simulations and statistical models designed to enable researchers, funding agencies, practitioners, and policymakers to make informed systematic decisions regarding priorities for studies of comparative effectiveness.

Last updated July 20, 2010