Lori M. Reilly,
On April 3, 2009, public testimony on comparative effectiveness
research was given at a meeting of the National Advisory Council
for Healthcare Research and Quality. The testimony represents
the views of the presenter and not necessarily those of the Agency
for Healthcare Research and Quality (AHRQ) or the Department
of Health and Human Services (HHS).
The Council provides advice and recommendations to the Director,
AHRQ, and to the Secretary, HHS, on priorities for a national
health services research agenda.
Comments for AHRQ NAC Meeting
Lori M. Reilly, Vice President, Policy & Research
April 3, 2009
The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to comment on conduct of comparative effectiveness research (CER) at AHRQ and the additional funding the agency has received for CER under the American Recovery and Reinvestment Act.
PhRMA appreciates the thoughtful approach AHRQ has taken over the past five years to implement the comparative effectiveness research program mandated under the Medicare Modernization Act. We also appreciate the opportunities we have had during this time to work collaboratively with AHRQ on this issue. Our work with AHRQ reflects our longstanding support for sound approaches to comparative effectiveness research. More details of our position on CER are available in our principles for government-supported health outcomes research adopted by our Board in 2004, principles in support of evidence-based medicine adopted in 2005, and congressional testimony in 2007.
PhRMA would like to raise two important issues as AHRQ and the National Advisory Council prepare to expand the agency's comparative effectiveness research. First, the need for openness and transparency, and second, the importance of pursuing a broad scope of research.
PhRMA supports the steps AHRQ has taken to provide openness and transparency in its Effective Healthcare program, including opportunities to recommend research priorities in public meetings and through AHRQ's Web site, creation of an advisory board comprised of a wide range of stakeholders, and the ability to comment on draft reports. As stated by Dr. Clancy in 2007, "transparency in all aspects of the process" is an important hallmark of the Effective Healthcare program.
We believe there are several additional steps AHRQ can take to improve openness and transparency. These include:
- Making the meetings of the Effective Healthcare Stakeholder Group open to the public, and providing meeting minutes and related materials to the public.
- Define criteria used to evaluate recommended research priorities, and provide a rationale for research topics when they are selected.
- Provide more than two weeks for public comment on draft reports.
Second, as AHRQ expands its research activities, it should continue working to address the range of research topics mandated by Sec. 1013 of MMA. This includes not only prescription drugs and medical technology, but also approaches to organization, management and delivery of care. AHRQ has undertaken a few studies in these areas under the Effective Healthcare Program, but much work remains to be done.
This broader scope of research is consistent with the growing recognition that addressing the needs of all patients, particularly the chronically ill, requires greater scrutiny of healthcare delivery systems. This includes a comparison of various care processes, disease management services, care coordination models, benefit designs, and other components that directly impact care quality and patient outcomes. Information on the comparative effectiveness of interventions is unlikely to be translated into practice unless we increase our understanding of the comparative effectiveness of delivery system strategies.
Simply put, while much attention is appropriately paid to evidence-based care, our delivery system too often fails to deliver care that is evidence-based. For example, as AHRQ has noted, there is a "rich body of clinical evidence" supporting diabetes treatments, but "the set of studies designed to help providers, patients, and policymakers improve the standard of care is not as strong."
This issue was highlighted at a March 20 forum at the Institute of Medicine on CER research priorities. At the meeting, a broad range of health care stakeholders called for research to address evidence gaps across the health care spectrum.
PhRMA supports AHRQ's efforts to advance evidence-based, patient-centered care through development of CER research. We appreciate the National Advisory Council's consideration of this important topic, and we look forward to continuing working with you on it. Thank you.
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