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9 Toward a Patient-Centered Strategy for Clinical Trials
Pages 75-84

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From page 75...
... Thus, the goals of clinical trials have important and inescapable political dimensions because of the choices that will be made about which trials will be done and the parameters under which they will be carried out. 1 This section is based on the presentation made by Larry Brown, Professor of Health Policy and Management, Mailman School of Public Health at Columbia University.
From page 76...
... While clinical trials should be robust and efficient and timely and accessible, they should also honor a lengthening list of social criteria and priorities: diversity of the study populations, meticulous patient safety, strict informed consent, rigorous institutional review, and, not least important, accountability with respect to investigators' conflicts of interest and the role of industry and private interests in sponsoring and shaping the trials. Although it obviously would require heavier investment in clinical trials in order to achieve all these goals, Brown said, it is not so clear where that money should come from.
From page 77...
... these impressive efforts, expectations of how quickly biomedical science can "solve" major health issues have been unrealistic. In 1965, when President Lyndon Johnson launched the quest for a fully implantable artificial heart (which he wanted to have signed, sealed, and delivered by Valentine's Day, 1970)
From page 78...
... Clearly, the clinical trials enterprise faces some different, more complicated problems than does basic research, which, Brown remarked, is in some ways the easy case. For basic research, Congress appropriates money, the money goes to NIH, and it is allocated to leading research scientists who carry out studies in their laboratories.
From page 79...
... What may be needed is a concerted effort by a range of organizations acting as net works with carefully coordinated strategies to raise the prominence and secure the legitimacy of the clinical trials enterprise. Following the suc cessful example of patient organizations, such as those for CF, Alzheim er's disease, and breast cancer, these crucial groups need to take on the challenge of forging links with medical specialty associations, academic medical centers, community physicians, and other relevant community organizations and leaders.
From page 80...
... Economists increasingly talk about the unsustainability of Medicare, Medicaid, and private health care spending, and Congress is at loggerheads over the way forward. In all domains of health care, cost concerns make this a serious and difficult time.
From page 81...
... Concluding Remarks In his concluding observations, Brown remarked that the nation has not moved faster in solving problems with clinical trials for a number of reasons, including, perhaps, because "clinical trials are means to the means to the end -- that is, cures and solving medical problems." Meanwhile, many more immediate items crowd the agendas of patient groups, payers, academic medical centers, NIH, and others. Clinical trials simply have not risen high enough to motivate the investment of political and budgetary capital that would bring the supply of resources for trials into line with the growing demand for trial results.
From page 82...
... Experiences such as those of 23andMe and the other consumeroriented websites described at the workshop suggest the depth of public interest in participating in clinical trials. Use of a web interface to provide registrants with instant feedback on survey questions is in striking contrast to the lack of information that participants in conventional trials -- and their physicians -- receive, according to Nancy Sung, Senior Program Officer, Burroughs Wellcome Fund.
From page 83...
... • Voluntary health organizations can work with a resource people trust -- their doctors -- who can act as information conduits and legitimate participation in trials and other disease advocacy activities. • Multicenter clinical research projects find that different trial sites enroll pa tients at markedly different rates, indicating that concerted efforts to reach out to the community and to persuade referring doctors to enroll their pa tients in a trial could make a difference.
From page 84...
... is a consortium of nearly 50 nonprofit, nongovernmental funders of biomedical research and includes numerous patient groups.5 5 The HRA fosters open communication and collaboration among its members; provides data and analysis about the funding of biomedical research and training by HRA member organizations; identifies gaps in funding and facilitates innovative grant making; and ad dresses key issues in accelerating research discovery and its translation. For more informa tion, see http://www.healthra.org/pdfs/HRA_fact_sheet_6_17_2011.pdf (accessed October 10, 2011)


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