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3 The Role of Other Stakeholders in the Clinical Research Enterprise
Pages 51-69

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From page 51...
... 3 The Role of Other Stakeholders in the Clinical Research Enterprise INTRODUCTION Myrl Weinberg, C.A.E. President National Health Council Now that this workshop has given us a better understanding of the different stakeholders' views, which are legitimate from their perspectives and from the standpoint of their organizations' mission and goals, it is even more imperative that we look for unique solutions that we can work together to apply.
From page 52...
... Barriers to receiving the high quality care that the country can produce include educational barriers, financial barriers (including inadequate insurance coverage for cutting-edge care) , and barriers within the health care delivery system that may make accessing high quality care difficult.
From page 53...
... Improving elements of the drug development process to ensure that new standards of care are available for patients as efficiently as possible is also important. The ACS has its own research program, which ranges from basic to clinical and applied, including epidemiology, psychosocial research, behavioral research, health policy, and health services research.
From page 54...
... The ADA is unique among voluntary health agencies in that it is actually two organizations in one, which is a benefit. It is the professional society for the 20,000 health professionals who specialize in diabeteseveryone from PhD scientists to practicing clinicians, to nurses and dieticians, to exercise physiologists and pharmacists.
From page 55...
... Second, the business system but also down the line for the case needs to be made that diabetes care Medicare system. makes sense, i.e., that good-quality care · ~ r 1 r 1 Cohn Graham IV will reduce future costs, not only for tne private payer system but also down the line for the Medicare system.
From page 56...
... Why not give people tax credits for taking care of their health? The long-term payoff might be a significant step forward.
From page 57...
... Turning evaluative research loose to hypothesis-driven mechanistic research produces research that is not aligned with our priorities for health care. One nuance is that research on the methodology of conducting evaluative research is basic research and should be hypothesis-driven.
From page 58...
... This realization comes at a time when health care premiums for employers and purchasers are predicted to rise by about 13% in the next year, and there is no downward trend in sight1 . To illustrate the magnitude of those concerns, a report in an unpublished study by the Midwest Business Group on Health and the Juran Institute estimated that the direct cost of poor quality and medical errors is $1,800 per employee per year, while the indirect costs, which include lost work days and productivity, are $500 per year for a worker with an average salary of about $32,000.2 These costs create a serious situation for those who purchase care and those who provide care.
From page 59...
... Tools may exist for assisting providers in making decisions and helping patients make decisions that meet their preferences. However, our understanding of the impact of various interventions for coordinating patient care, improving quality, and eliminating waste and medical errors is still in its infancy.
From page 60...
... As the recipients of health care dollars, health care providers including health plans, hospitals, and physicians play a prominent role in the allocation of health care resources and the quality of care received for those dollars. Research is needed on how providers can partner with purchasers to achieve creatively the objectives outlined in Dr.
From page 61...
... HEALTH SERVICES RESEARCH IN VOLUNTARY HEALTH ASSOCIATIONS Mary Woolley of Research! America began a discussion of the health services research conducted by voluntary health associations by responding to the list of needs presented by John Graham of the ADA, which largely involve perform
From page 62...
... She suggested that this approach could be promoted more vigorously so that even more dollars flow into those important areas. Enriqueta Bond of the Burroughs-Wellcome Fund asked whether the voluntary organizations are also viewing the emerging area of health services research as a major need for advancing the management of particular chronic diseases, and whether they are also advocating for dollars in this area.
From page 63...
... THE ROLE OF THE DEVICE INDUSTRY IN THE CLINICAL RESEARCH ENTERPRISE Susan Foote, J.D. Board Member Medical Technology Leadership Forum The Medical Technology Leadership Forum is a medical technology think tank that brings together a broad range of representatives from what is called the medical technology community, which includes physician organizations, university and research centers, health plans, device firms, bioengineering organizations, and patient groups.
From page 64...
... The Medical Technology Leadership Forum is not clear yet about how those rules should evolve. Nevertheless, the rules could pose an enormous barrier unless they are carefully drawn.
From page 65...
... We see as very important the continued funding of not just the clinical research at large, but also the research produced by the next generation of researchers clinical health services researchers and epidemiologists. AHRQ funds research and also conducts research.
From page 66...
... The National Guideline Clearinghouse has well over 1,000 clinical practice guidelines. For seven years, Larson has chaired the committee for CDC that There is very little external validity, i.e., little evidence as to how well these guidelines will work when widely applied nationally or globally.
From page 67...
... Robert Califf of Duke University mentioned that every practitioner knows that the current guidelines apply to only a small part of his or her everyday professional life. In cardiology we have solid evidence for a few factors that affect major outcomes.
From page 68...
... A representative from the Medical Technology Leadership Forum emphasized the unique characteristics of the medical device industry and the challenges the industry faces in funding research, obtaining timely research results, and evaluating those results. A representative from the Agency for Healthcare Research and Quality described the mission of the agency and spoke about its role as a broker of public and private collaborations and partnerships.


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