Conference on Methodological  Challenges in Comparative Effectiveness Research

Methodological Challenges in Comparative Effectiveness Research

Thursday, December 2, 2010; 8:00 AM – 5:15 PM
Friday, December 3, 2010; 8:00 AM – 3:30 PM

Masur Auditorium
Building 10 (Clinical Center)
National Institutes of Health
Bethesda, Maryland

A national conference to advance the innovative, valid and efficient methodological tools of tomorrow.


NIH and AHRQ are co-sponsoring a conference on “Methodological Challenges in Comparative Effectiveness Research” to be convened on December 2nd and 3rd on the main NIH campus in Bethesda, Maryland. The conference will make use of case studies that pose difficult questions about what kinds of research, methods and analyses should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies. The cases will address a variety of important comparative effectiveness research questions facing U.S. researchers, care providers, health systems, and patients. Topics include:

  • Comparative effectiveness of surgical and radiotherapy treatments for prostate cancer: Best methods for studying multilevel heterogeneous effects.
  • Comparative effectiveness of medical and surgical treatments for stable ischemic heart disease within subgroups of patients and in the face of rapidly evolving treatments.
  • Comparative effectiveness and costs of imaging strategies for diagnosing and monitoring patients with cancer.
  • Evaluation of two high profile comparative drug safety cases: Aprotinin and Rosiglitazone.
  • Challenges of designing a “Learning Healthcare Systems” for Comparative Effectiveness Research in “Learning Healthcare Systems.”

In addition to the case-based discussions noted above, consumers, economists, methodologists, policymakers and statisticians will present two additional sessions:

  • Methods for Addressing Confounding in Observational Studies
  • Value of Information Techniques for Setting Research Priorities

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This conference is being convened at a historic moment for the biomedical, clinical, biostatistical, research design and health services research communities. With the passage of the Patient Protection and Affordable Care Act (PPACA), the nation stands at a critical juncture, as it ramps up efforts to streamline the delivery of high quality healthcare, bend the cost curve and ensure improved health outcomes.

With the advent of healthcare reform, the research community embarks upon an unprecedented effort to determine which health care interventions and processes work best for the diagnosis, treatment and monitoring of a wide range of medical conditions. The PPACA emphasizes the importance of comparative effectiveness research to assess the outcomes of interventions while identifying individual factors that could help guide the delivery of the right treatment to the right patient at the right time.

In addition, the increased national commitment to CER stimulated by the American Recovery and Reinvestment Act of 2009 (ARRA) provides an unprecedented opportunity to develop and enhance research methods that will benefit the nation’s health for years to come. Recent reports by the Federal Coordinating Council (FCC) and by the Institute of Medicine call for stepped up investments in CER research methods innovation. Such initiatives will prove critical to improving the validity, credibility and efficiency of CER methods, given the limitations of all commonly applied approaches-- ranging from prospective observational studies to large scale randomized trials, from technology assessments to meta-analyses.

This meeting aims to explore current methodologic, data analytic, infrastructure and database research challenges in order to help develop a vision for shaping the methodological tools of tomorrow. The development and enhancement of new methodologic, design and evidentiary approaches will help to ensure the credibility, validity and reliability of applicable research findings to a diverse population, and to assist practitioners, patients and policymakers to come to the right personalized decisions.

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The audience will be comprised of clinical, biomedical and health services investigators, consumer advocates, policymakers, healthcare executives and industry representatives, in addition to NIH, AHRQ, CMS and FDA staff, respectively.

We look forward to your participation throughout the conference. There is no charge to attend this meeting, but registration is required. Early registration is encouraged.


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