Introduction to the Workshop
Sean Tunis, M.D., M.Sc.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Allan Korn, M.D.
Senior Vice President and Chief Medical Office
Blue Cross Blue Shield Association
(Presented by Sean Tunis)
The topic of this workshop, The Role of Purchasers and Payers in the Clinical Research Enterprise, is critical to the quality of patient care, in the sense that the quality of care depends on the quality of information underlying health care decisions. Without high-quality empirical information to support decision making in health policy and clinical care, the quality of patient care cannot possibly be improved. The role of the Clinical Research Enterprise itself is underemphasized and under-highlighted in the quality-of-care discussion. Little consensus exists as to what role purchasers and payers should play in the Clinical Research Enterprise and how that role can be improved. The Clinical Research Roundtable hopes to make headway in addressing these issues through this workshop.
Without high-quality empirical information to support decision making in health policy and clinical care, the quality of patient care cannot possibly be improved.
The Clinical Research Enterprise is a broadly defined term that includes a wide spectrum of research and its applications—from the beginnings of human-oriented practical bench-top research and its application to patient care, to clinical epidemiology, health services research, and outcomes research. Even further along the spectrum is the incorporation of these findings into health care in the community. The view of Sean Tunis of the Centers for Medicare and Medicaid Services and Allan Korn of the Blue Cross Blue Shield Association, as self-described evidence-based decision makers in large insurance organizations, is that, as currently configured, the Clinical Research Enterprise does not produce
an adequate volume or quality of information to support policy decision making at a number of different levels—hospitals; physician groups; and large organizational levels such as the Medicare program and health insurance companies.
The Clinical Research Enterprise does not produce an adequate volume or quality of information to support policy decision making at a number of different levels—hospitals; physician groups; and large organizational levels such as the Medicare program and health insurance companies.
Groups poorly served by the output of the Clinical Research Enterprise are consumers, clinicians, payers, purchasers, and health care policy makers—a fairly large and important group of end users of research. Particularly poorly served are clinicians, who need high-quality information that speaks to the practical questions that they encounter in day-to-day patient care, and consumers, who count on the quality of evidence available to them to properly inform them in making health care decisions.
For example, many women have had to make personal decisions about the use of hormone replacement therapy for the prevention of osteoporosis and its complications. For years, that decision was driven largely by the purported impact of hormone replacement therapy on cardiovascular disease, because that health outcome far outweighed any impact on osteoporosis risk in terms of magnitude of morbidity. Many years of epidemiologic and observational studies suggested that hormone replacement therapy was beneficial in terms of cardiovascular disease. However, well-designed prospective clinical trials recently demonstrated that the benefit was either nonexistent or extremely small.
The example shows that personal decisions that patients and physicians make about health care depend critically on the quality and integrity of the information produced by the Clinical Research Enterprise. If the enterprise is not producing an adequate number of studies, of adequate reliability, to properly inform those decisions, it is failing an important group of users. That perception underlies the urgency and importance of making some headway in this workshop, identifying follow-up activities, and determining how the Clinical Research Enterprise can be more productive in the area of studies that support this kind of decision making.
When government and private health insurers try to develop coverage policy in an evidence-based fashion—for instance, deciding which new and old technologies to pay for—the evidence is often lacking. Increasingly, large systematic reviews of published clinical literature are commissioned on the most commonly used technologies, and they generally reveal that the research available is inadequate to support evidence-based decision making. For example, it is almost impossible to develop sensible evidence-based coverage policy on the use of virtually any type of new wound care therapy on patients with pressure ulcers. We just do not know whether air fluidized beds, electrical stimulation, hyperbaric oxygen, or any number of other things do anything to speed the healing of
pressure ulcers. Yet we spend tens of millions of dollars and much patient and caregiver time on those sorts of interventions. In this area the Clinical Research Enterprise is unaccountably silent. This problem grows more acute as the pace of medical innovation increases. Although huge sums of money are invested in the development of promising new technologies, a matching investment in the value of the clinical utility of new innovations is lacking. Thus, potentially useful innovations are put into the marketplace, at a faster and faster rate, yet there is no matched effort to determine how those innovations appropriately fit into the armamentarium of clinical care.
Thus, potentially useful innovations are put into the marketplace, at a faster and faster rate, partially the result of doubling the budget of the National Institutes of Health; yet there is no matched effort to determine how those innovations appropriately fit into the armamentarium of clinical care.
Payers, certainly, but also all other end users, such as purchasers and consumers, must be much more active participants in the Clinical Research Enterprise. They must participate in setting priorities for clinical research, assisting in the design of clinical research, and probably participating to a much greater degree in its funding. Certain stakeholders also need to become involved in recruiting patients into clinical research to answer important research questions. Unless these end users become active participants in every phase of the Clinical Research Enterprise, it will not change dramatically to better serve their needs.
Similarly, the Clinical Research Enterprise must look to the end users much more as true partners in the enterprise rather than as “deep pockets” to provide additional funding for clinical research. What is needed is not more support for the clinical research that is already being done, but rather support for a different kind of clinical research. Some examples of this new type of research already exist. The Veterans Administration performs applied, practical clinical research that supports decision making. Another program, the Centers for Education and Research on Therapeutics (CERT) funded through the Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ), has begun a number of studies to fill the gaps in what physicians and patients need to know to support decision making.
Similarly, the Clinical Research Enterprise must look to the end users much more as true partners in the enterprise than as “deep pockets” to provide additional funding for clinical research.
The research community must recognize that a move to this new type of research leads down a long, difficult road and marks a serious shift in the empha
sis of the Clinical Research Enterprise that poses huge challenges in methodology and infrastructure. Researchers need to be properly trained in this new type of clinical research, or in research that answers slightly different questions. Some of this shift in emphasis is being driven unilaterally by purchasers and payers who are increasingly taking a more active role. The goal can be accomplished by the payer-purchaser community coming together and bringing its funds and resources to bear on this movement in a new direction. It can be best achieved, however, when all components of the enterprise cooperate with each other.
The research community must recognize that a move to this new type of research leads down a long, difficult road and marks a serious shift in the emphasis of the Clinical Research Enterprise that poses huge challenges in methodology and infrastructure.