Public Engagement and Clinical Trials New Models and Disruptive Technologies: Workshop Summary (2012) / Chapter Skim
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8 The Health System's Structure and Culture
8 The Health System's Structure and Culture
Pages 65-74
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From page 65... ...
Fundamental obstacles hindering the academic clinical trials enterprise in the United States, as cited by Eric Rose, Chair of the Department of Health Evidence and Policy, Mount Sinai School of Medicine, are cultural, economic, and ethical. These obstacles are responsible for • t he slow pace of designing and implementing trials; • d eclining patient enrollment at trial sites; • l oss of clinical investigators to other work; and • t he failure to produce evidence for optimal clinical practice.
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From page 66... ...
Community physicians can engage in a number of points across the lifecycle of a clinical trial -- from the generation of research questions, service as the principal investigator, facilitating the recruitment and retention of patients, and community-focused dissemination of trial results. Panelists and work shop participants discussed a number of challenges and potential solutions to facilitate the development of effective connections between community physicians and researchers conducting clinical trials in academic medicine.
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From page 67... ...
a Based on the panel discussion with Rafat Abonour, Chairman, Hoosier Oncology Group, Associate Dean for Clinical Research, Professor of Medicine, Professor of Pathology and Labo ratory Medicine, Indiana University; Sanford Friedman, Associate Clinical Professor of Medicine of Cardiology, The Mount Sinai Hospital; Carol Horowitz, Associate Professor, Department of Health Evidence and Policy, Mount Sinai School of Medicine; Ramon Murphy, Clinical Professor of Pediatrics and Preventive Medicine, Vice-Chair of Department of Pediatrics, Voluntary Affairs, Associate Director, Mount Sinai Global Health Center, and Director, Off-Site Pediatric Residency Program at the Mount Sinai School of Medicine; and Hugh Sampson, Professor of Pediatrics and Immunology, Mount Sinai School of Medicine, Director of the Jaffe Food Allergy Institute, Dean for Translational Biomedical Research, and Principal Investigator and Director, Conduits, Institutes for Translational Sciences, Mount Sinai Medical Center. This box provides an integrated summary of each of their remarks and discussions with workshop participants during the panel, and should not be construed as reflecting consensus or endorsement by the planning committee, the Forum, or the National Academies.
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From page 68... ...
Finally, Rose said, specialists frequently perceive randomization of patients referred to them by physicians for a treatment as a threat to their referral relationships and their standing in that community. Ethical Obstacles Among the ethical obstacles a researcher must overcome are those involving perception and misperception; for example, the perception that trial participants are being treated as guinea pigs or that randomization is a threat to the physician's unfettered exercise of clinical judgment.
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From page 69... ...
. Reinforcing the "learning organization" goal articulated in an earlier ses sion, Rose said that "medical quality measurement is essentially a broad array of ongoing observational clinical trials," and he further argued that an academic medical center that is not managing quality, using the tools and skills integral to observational trials is, by definition, not a highquality institution.
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From page 70... ...
are cancers of the smooth muscle cells that had previously been undistinguishable but are now recognized as separate diseases. Laboratory scientists studying mutant cells in the gut found a causative target for GISTs, and further research showed that, if an abnormal enzyme is shut down, the GIST cells die.
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From page 71... ...
In the latter case, Bayer Oncology had supported earlier phases and was willing to participate in the phase III trial because it believed that if the company did the work on its own it would require "an extra seven years and $50 million," Demetri said. Although sarcomas collectively account for only 1 percent of human cancer cases, the knowledge gained through identification of successful molecularly targeted therapies appears applicable to other kinds of can cers and has shown the real value of public-private collaboration.
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From page 72... ...
As a trial proceeds, communication and interaction with physicians, trial study coordinators in different sites, and the nurses involved are scrupulously maintained, said James O'Dell, RAIN, Larsen Professor, Vice Chair Internal Medicine, Chief of Rheumatology, University of Nebraska. The first RAIN trial, results of which were published in the New England Journal of Medicine, took 7 years to reach publication (O'Dell et al., 1996)
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From page 73... ...
During the workshop discussion period, a participant suggested that, as the United States moves toward accountable care organizations, all of the incentives will be against physicians taking the time necessary to adequately inform patients about research projects. That difficulty may be counterbalanced in the future if it becomes feasible to collect study data directly from EHRs.
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