The Role of Purchasers and Payers in the Clinical Research Enterprise Workshop Summary (2002) / Chapter Skim
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4 Opportunities and Challenges in the Clinical Research Enterprise
4 Opportunities and Challenges in the Clinical Research Enterprise
Pages 70-81
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From page 70... ...
It is recognized that a particular member may not ask the "right" question from the view of the overall enterprise. As a group, we need to figure out how to incent the individual members of the Clinical Research Enterprise to ask the questions that need to be answered and move beyond the second translational block from clinical knowledge to practice.
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From page 71... ...
Outcomes research examines the consequences of medical treatment that are noticeable to patients and their families. It includes typical dichotomous variables, such as whether people live or die, and the so-called humanistic outcomes such as quality of life, functional status, and patient satisfaction things that are vitally important to patients and their families.
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From page 72... ...
Movement from outcomes research to outcomes management or disease management occurs when one seeks to produce desirable outcomes in usual clinical settings. It involves marrying the practice of medicine with the principles of public health.
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From page 73... ...
By setting objectives and goals and using The new paradigm is a dynamic relationship in which information is shared and the physician, appropriately informed, can present choices to patients, who can then make informed decisions. Lou Sherwood 1 Sueta CA, Chowdhury M, Boccuzzi SJ, Smith SC, Alexander CM, Londhe A, Lulla A, Simpson RJ.
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From page 74... ...
Merck recently sponsored a major observational study called NORA the one year follow-up study of a cohort of 200,000 women.3 The background for this study was the magnitude of the burden of osteoporotic fractures and the fact that bone density measurements have been shown to predict fracture risks, along with other risk factors. The study objectives were to report the occurrence of low bone mass in a large cohort of ethnically diverse post-menopausal women, examine the relationships between bone density and fractures, and relate other risk factors to fracture risk.
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From page 75... ...
These methods include changing medical school curricula, building systems and infrastructure, and orienting people in this direction. INTEGRATED PATIENT-CENTERED CARE Focusing the discussion on integrated approaches to patient care, Myrl Weinberg of the National Health Council described an initiative called integrated patient-centered care, which goes beyond disease management.
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From page 76... ...
He postulated that an important clinical question about osteoporosis prevention in women at low risk would be whether taking calcium supplements twice a day had as much effect on bone density loss as taking Fosamax. Lou Sherwood replied that Merck did conduct a three-armed study that examined the effects of calcium supplementation.
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From page 77... ...
Clinical trials are quantitatively driven by the pharmaceutical industry first, the biotechnical industry second, and now the NIH. He asked, what happens after that, at the second translational block?
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From page 78... ...
Hugh Tilson of the University of North Carolina emphasized that the ethics and politics of who pays for research should be revised often, remarking: "Happy are the circumstances when the public health and the private wealth converge." So much work needs to be done that if industry receives some gain from the research and is willing to pay for it, the effort is commendable. Hugh Tilson commended Lou Sherwood on the published article on the osteoporosis study, not just because it is a good article, but because Merck scientists are listed as authors.
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From page 79... ...
The purpose was to create a context for industry and academia to come as partners and develop research projects jointly, and to propose these projects to industry and voluntary partners for co-funding and collaborative work (including industry researchers as authors on research articles)
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From page 80... ...
On the other hand, we face an issue when, for example, patients demand bone marrow transplants that are probably more harmful than helpful; demand spiral CT scans if they have been tobacco smokers, long before the NIH reports whether or not results from these scans are meaningful; or demand spiral CT scans of the coronary arteries as screening tools rather than diagnostic aids. We want to demand the right things.
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