By Rebecca Adams, CQ HealthBeat Associate Editor
January 21, 2011 -- The new nonprofit institute assigned by the health care law to fund comparative effectiveness research gave a sign that it is gearing up: It announced the members of a key committee that will shape the way the studies will be conducted.
The Patient-Centered Outcomes Research Institute (PCORI) also held its second board meeting in Los Angeles and made plans for a March 7-8 meeting in St. Louis. Although the organization doesn't yet have an executive director, chairman Eugene Washington of the University of California at Los Angeles Geffen School of Medicine is busy discussing priorities with board members. PCORI officials are expected to create a list of research priorities and start handing out funding for studies in the coming months.
PCORI was created in the health care law (PL 111-148, PL 111-152) as a way to coordinate research comparing medicines, devices or methods of delivering care for patients to figure out what works best. The federal government has funded comparative effectiveness research for decades, and some government-funded research will continue on a separate track through the National Institutes of Health and the Agency for Healthcare Research and Quality (ARHQ).
But PCORI will serve as a centralized source of funding for comparative studies. Comparative effectiveness studies became somewhat controversial in the health care debate because some critics feared that federal officials at Medicare or other health programs might decide to limit coverage for treatments that are shown in studies to be less effective than alternatives.
ARHQ Director Carolyn Clancy, who serves on the PCORI board, acknowledged that there is "lots and lots of apprehension" about comparative studies, including questions about whether the research could somehow inhibit innovation. She argued that "we will actually accelerate the uptake of new innovations" by being able to rapidly identify which patients will benefit most from different types of care.
"Early on in CER [comparative effectiveness research], people were talking about winners and losers, and really it's about precision and how we apply the science," she told an audience at the Congress on Health Insurance Reform, a conference sponsored by the policy research publication Health Affairs. Studies can help guide physicians who are trying to tailor treatments to individual patients' needs.
Clancy also said that all of the federally funded efforts to improve quality—whether through PCORI, ARHQ or other entities—will need to be closely coordinated with the private sector. "It can't be top-down," she said in an interview after her speech. "It has to be collaborative."
The 15-member methodology committee will play a key role in determining how studies are conducted. Washington, as chair of the PCORI board, will select the chair of the committee. The new members of the methodology panel are largely physicians, academics, and representatives of groups that conduct comparative effectiveness studies, such as the executive director of the Blue Cross and Blue Shield Association Technology Evaluation Center.
"These committee members will play a critical role in shaping methodological standards for research, and, with their knowledge and qualifications, the experts who have been appointed to serve on the committee are well-positioned to achieve the committee's goals," said Robert Dubois, chief science officer of the National Pharmaceutical Council, whose members include major drug companies. "The work of this group is foundational to achieving PCORI's mission."
The members of the committee are:
- Naomi Aronson, Executive Director, Blue Cross and Blue Shield Association Technology Evaluation Center.
- Ethan Basch, medical oncologist and health services researcher, Department of Medicine and Department of Epidemiology, Memorial Sloan-Kettering Cancer Center.
- Alfred Berg, professor, Department of Family Medicine, University of Washington.
- David Flum, professor, Department of Surgery and Adjunct Professor, Department of Health Services, University of Washington Schools of Medicine and Public Health; Attending physician, General Surgery, University of Washington Medical Center.
- Sherine Gabriel, Professor of Medicine and of Epidemiology, and the William J. and Charles H. Mayo Professor, Mayo Clinic.
- Steven Goodman, Professor of Oncology, of Pediatrics, of Epidemiology and of Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health.
- Mark Helfand, Professor of Medicine and of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University; Staff physician, Portland VA Medical Center.
- John Ioannidis, the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director, Stanford Prevention Research Center, Stanford University School of Medicine.
- David Meltzer, director, Center for Health and the Social Sciences, Chief of the Section of Hospital Medicine, and Associate Professor, Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies, University of Chicago.
- Brian Mittman, director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System.
- Robin Newhouse, Assistant Dean, Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing.
- Sharon-Lise Normand, Professor of Health Care Policy, Harvard Medical School and Professor of Biostatistics, Harvard School of Public Health.
- Sebastian Schneeweiss, Associate Professor, Department of Medicine, Harvard Medical School and Associate Professor, Department of Epidemiology, Harvard School of Public Health; Vice Chief and Director, Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital.
- Mary Tinetti, Professor of Medicine, Epidemiology, and Public Health, Division of Geriatrics, Yale University School of Medicine; Director, Program on Aging, Yale University School of Medicine.
- Clyde Yancy, Chief, Cardiology, Northwestern University Feinberg School of Medicine; Associate Director, The Bluhm Cardiovascular Institute, Northwestern Memorial Hospital.