Session Topic: Comparative Effectiveness Research (CER)

Session Goals

The goals of this session are to identify critical opportunities for Comparative Effectiveness Research (CER) in diseases within the NIAMS mission, and to begin developing a strategy for how the Institute should stimulate and support this important area of clinical research.

Background

Under the American Recovery and Reinvestment Act (ARRA) of 2009, $1.1 billion has been allocated to CER [$400 million to the Secretary of the Department of Health and Human Services (DHHS), $400M to NIH, and $300M to the Agency for Healthcare Research and Quality (AHRQ)]. This investment demonstrates the importance the Nation places on research to inform health-care decisions for physicians and patients and to improve health outcomes. The Federal Coordinating Council (FCC), created under ARRA to advise the DHHS Secretary about CER, was charged with defining CER and contracting with the Institute of Medicine (IOM) to list the Nation’s highest CER priorities. The FCC defines CER as 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. Its purpose is to improve health outcomes by disseminating evidence-based information about which interventions are most effective, for which patients, under specific circumstances. It primarily focuses on drugs, devices, procedures, diagnostics, and the approaches to the delivery of care. Of note, CER’s relevance to “real-world” situations distinguishes it from comparative efficacy research, which is conducted in “ideal” settings created by the environment of clinical trials where the patient populations, conditions, and treatments are highly selective.

In June 2009, the IOM released a report recommending 100 national priority research areas in CER related to a wide range of diseases. Many such as osteoarthritis, back pain, rheumatoid arthritis, and psoriasis fall within the NIAMS mission.

Expected Session Outcomes

During the discussion, we hope to identify

  • Key CER gaps and opportunities within the NIAMS portfolio.
  • Key stakeholders and strategies to enhance NIAMS interactions with patients, health care providers, and researchers.
  • Approaches to develop a research base to enhance future comparative effectiveness research opportunities.

Key Questions

  • How can NIAMS engage the patient, health care provider, and research communities as it further develops its CER portfolio? How should the NIAMS collaborate/partner with other NIH institutes or agencies?
  • How can we evaluate the impact of NIAMS-supported CER projects? What are the most meaningful or predictive performance indicators?
  • Which specific disease areas and populations are ready for CER investigations? How could the NIAMS position these research areas to remain competitive should additional CER funds become available?
  • How can the NIAMS better position the portfolios that are not yet ready for comparative effectiveness research?
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