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Joint NIH/ECRI Institute Meeting Focuses on Comparative Effectiveness and Personalized Medicine

Legislative Update
October 20, 2010

Agency for Healthcare Research and Quality (AHRQ) Director Carolyn Clancy, M.D. and National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D. take questions from meeting attendees after their keynote remarks
Agency for Healthcare Research and Quality (AHRQ) Director Carolyn Clancy, M.D. and National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D. take questions from meeting attendees after their keynote remarks
On October 19-20, the National Institutes of Health (NIH) and the ECRI Institute jointly sponsored a meeting entitled Comparative Effectiveness and Personalized Medicine: An Essential Interface. The meeting served many purposes, the most important of which was to better understand comparative effectiveness research (CER) in general, as well as its use in evaluating clinical outcomes across study populations. It also enabled policymakers, such as NIH Director Francis Collins, M.D., Ph.D., and Agency for Healthcare Research and Quality (AHRQ) Director Carolyn Clancy, M.D., to explain the emphasis on CER in the Patient Protection and Affordable Care Act and in American Recovery and Reinvestment Act (ARRA) funding.

The speakers addressed how the United States will be embarking on an unprecedented effort to determine which healthcare intervention works best for the treatment of a given condition or disorder, especially the key role of personalized medicine in ensuring the capacity to identify both individual and subgroup differences within populations. The sensitivity to personalized medicine will help clinicians and patients better predict which intervention will deliver the optimal treatment to the appropriate patient at the right time.

A series of stakeholders discussed the infrastructure and database needs necessary to generate the appropriate evidence, as well as the regulatory, ethical, and societal factors affecting the research. In his keynote comments, Dr. Collins acknowledged that, although CER has been identified as one of his top five priorities, NIH has been funding such research for some time in the areas of prevention, diagnosis, and treatment. He stressed that NIH has been conducting CER research in 88 of the 100 priority areas, as identified by the Institute of Medicine (IOM). As former Director of the National Human Genome Research Institute (NHGRI), he commented that, "CER should be guided by the emerging science of genomics and personalized medicine, and CER studies should include consideration of genomics and environmental exposure." Dr. Clancy reported on the $1.1 billion in ARRA funding to Department of Health and Human Services (DHHS) agencies for CER, $400 million of which was transferred to NIH.

The NEI has tentatively reported that $1.2 million in CER research funding has been awarded to vision researchers from the $400 million in ARRA funding provided to NIH. NEI ARRA-funded CER studies include the comparative effectiveness of medical interventions for primary open angle glaucoma (POAG) and the comparative effectiveness of novel interventions for retina of prematurity (ROP). These studies are important, because glaucoma is the second leading cause of preventable blindness in the United States, disproportionately affecting African Americans and Hispanics, while ROP affects 15,000 children each year, about 400-600 of whom progress to blindness.

These CER studies are in addition to the ongoing NEI-funded Comparison of Age-related Macular Degeneration (AMD) Treatments Trials (CATT) and the NEI-funded Diabetic Retinopathy Clinical Research (DRCR) Network’s comparative effectiveness trial, in which initial results reported earlier this year confirmed that laser treatment for diabetic macular edema, when combined with injections of the FDA-approved drug Lucentis, is more effective than laser treatment alone, which has been the standard of care for the past 25 years.