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.

—Sean Tunis

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



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