Testimony on Comparative Effectiveness Research
Teresa Lee, Advanced Medical Technology Association (AdvaMed)
Before the National Advisory Council for Healthcare Research and Quality
April 3, 2009
My name is Teresa Lee, and I am here on behalf of AdvaMed, the Advanced Medical Technology Association. AdvaMed represents the medical device and diagnostics products industry, and our members produce nearly 90 percent of the health care technology purchased annually in the United States.
We greatly appreciate the opportunity to comment today and will focus on implementation of comparative effectiveness research (CER) funds allocated to AHRQ in the American Recovery and Reinvestment Act of 2009. We have comments on three subjects today: (1) transparency and stakeholder input; (2) selection of the CER priorities; and (3) content of the research topics.
Transparency and Stakeholder Input
First, AdvaMed recognizes the strides AHRQ has made in enhancing transparency and stakeholder input in many of its functions. We have been particularly impressed with the agency's willingness to seek public input on the research questions and draft reports issued by the Effective Health Care Program (created under section 1013 of the MMA). With regard to any AHRQ research funded by the Recovery Act, we recommend that AHRQ continue to employ the processes and procedures it has developed for the Effective Health Care Program to engage the public in its operations. In addition, to the extent that AHRQ conducts or supports any original research, stakeholders with relevant scientific, clinical, or technical expertise should have the opportunity to provide specific comments or guidance on research protocols and study designs.
Selection of CER Priorities
Second, regarding CER priorities, AdvaMed recommends that AHRQ first focus on efforts to improve the infrastructure for comparative effectiveness research. Using the Recovery Act funds to improve health services research workforce training would be a good way to lay the groundwork for any longer term efforts to bolster CER. In particular, we think that AHRQ sponsorship of interactive forums where private sector researchers can work shoulder-to-shoulder with AHRQ grantees, who will be doing systematic reviews, would be valuable so that these clinical and technical experts can learn from one another.
Another priority area should be the development of improved pathways to translate research into practice. As you know, one study found that it takes 17 years on average for clinical research results to enter into mainstream practice. To ensure that comparative effectiveness research successfully advances practice, we should invest in developing better methods and tools to make sure that clinicians and patients understand and integrate research findings.
With respect to specific research subject areas, AdvaMed recommends that the CER agenda be prioritized with a focus on areas that have major clinical significance and that will have the greatest impact on delivery of health care to patients in the United States. By way of example, chronic disease management and hospital-acquired infections and conditions represent significant CER opportunities. Selecting CER priorities along these lines would be consistent with the recommendations set forth by the IOM in its 2003 report "Priority Areas for National Action: Transforming Health Care Quality." From a public health standpoint, it makes sense to follow a broad-based approach that is not purely disease-based, but rather includes preventive care and behavioral health as means to improve quality.
Content of the Research Topics
Third, AdvaMed supports using comparative effectiveness research to inform medical decisions. The objective of comparative effectiveness research should be to provide better evidence for physicians and patients to use in making individual clinical decisions. It should enhance, not hinder or preclude, a physician's ability to exercise independent professional medical judgment in providing care to patients, so that patients have access to the interventions that best meet their individual needs and circumstances. That is why it is essential that clear, comprehensible study results are disseminated to the patients and the physicians who treat them. It is why these results should not result in one-size-fits-all coverage recommendations.
In addition, we believe that the comparative effectiveness research pursued should focus on clinical effectiveness, not cost effectiveness. As stated in the Conference Report to the Recovery Act, the purpose of the funding is for the conduct or support of research on "clinical outcomes, effectiveness, risk and benefits." Moreover, using this research to deny access to appropriate treatments for individual patients with individual medical histories and individual needs should not be the objective. AdvaMed supports the conduct of clinical comparative effectiveness research and believes that such research will ultimately improve quality of care and have a favorable impact on overall efficiency in the health care system.
Thank you for your time today.