Comparative Effectiveness Research (CER) has moved into the spotlight at HHS since the American Recovery and Reinvestment Act of 2009 appropriated $1.1 billion for CER, with $400 million allocated to NIH, the remainder to AHRQ, and to the Office of the Secretary. The Director of NIH, Francis S Collins, M.D, PhD, recently said at “The Atlantic’s 2011 Health Care Forum” held in Washington D.C on April 7th. “NIH is committed to CER as a research priority to encourage new research and new ideas.”
Dr. Collins noted that CER can be an effective tool to generate evidence to demonstrate what works, help to make medical decisions, support decisions based on quality and value, and possibly help to lower healthcare costs. The key challenge is to get the results of CER studies out to providers, payers, and the public.
He further commented that CER will be guided by the emerging science of genomic and personalized medicine. The research will study what groups may or may not respond to an intervention. It is also important for CER studies to include participant genomic and environmental exposure data to help scientists understand why some individuals benefit from a specific treatment while others do not.
Several NIH Institutes support research involving Health Maintenance Organizations (HMO). In order to advance the science of healthcare decision-making, the HMO Research Network Collaboratory was formed and includes 16 integrated health systems. The primary goal is to accelerate large epidemiology studies, clinical trials, and healthcare services research so that the Collaboratory can focus on risk factors, rate diseases, CER, patient accrual, and reimbursement models.
The Collaboratory has issued a Request for Information (RFI) titled “Input on Strategies for Leveraging Existing Health Data Linked to New or Existing Bio-specimen Repositories for Large Scale Epidemiology Research” due June 1, 2011. The RFI is seeking comments from organizations and individuals that have repositories adaptable for research.
The Collaboratory also issued a Funding Opportunity Announcement (FOA) “NIH-HMO Collaborator Coordinating Center” looking to develop, expand, and evaluate the infrastructure needed to support the project’s long-term objectives. The deadline for the FOA is May 27, 2011.
NIH is working closely with the non-profit “Patient-Centered Outcomes Research Institute” (PCORI) established by ACA to organize and fund research, provide a peer-review process for primary research, and to disseminate research findings. Dr. Collins pointed out that NIH and AHRQ are embracing PCORI to build on the investment in CER to provide well validated evidence-based approaches.
There are several studies and program that have in the past or are currently using knowledge gained from CER that went out to communities to help the general population and providers receive up-to-the-minute research data. A good example is the NIH “Diabetes Prevention Program” (DPP) with total funding of $267,589,000 that studied 3,000 plus adults at risk for developing Type 2 diabetes.
The study followed participants for ten years and looked at not only the lifestyle changes needed by individuals at risk for Type 2 diabetes but also studied treating participants with the drug metformin. A decade later, both lifestyle changes and metformin were still found to lower the risk for Type 2 diabetes. The information obtained from DPP was then broadly disseminated into communities and to providers.
In another campaign program to prevent Type 2 diabetes, the National Diabetes Education Program(NDEP) through NIH, CDC, plus more than 200 public and private organizations developed the “Small Steps, Big Rewards” program.
The NDEP through this program created campaign messages and materials for people at risk for diabetes including African Americans, Hispanic and Latino Americans, Native Americans and Alaska Natives, Asian Americans and Pacific Islanders, woman with a history of gestational diabetes, and older adults. NDEP and their partners are promoting diabetes prevention and sending the information to healthcare professionals so that they will have the tools to help their patients take small steps to prevent or delay the disease.
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