Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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6 Suggesting an Agenda for Transforming Elements of the Clinical Trials Enterprise
6 Suggesting an Agenda for Transforming Elements of the Clinical Trials Enterprise
Pages 63-80
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From page 63... ...
The chairs of the workshop sessions delivered summaries of their respective discussions. The summaries and workshop discussions gen erated several key themes on the need for, and possible avenues for transforming, the CTE.
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From page 64... ...
Convergence of Clinical Research and Clinical Practice • ncorporate clinical research and clinical trials into continuous quality improve I ment activities of the health care system. Most clinical decisions apparently are not yet based on scientific evidence; broad engagement of, and partnership with, community health care providers and patients could provide excellent opportunities to generate valid, reliable, and relevant evidence and incorporate it into medical practice.
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From page 65... ...
65 SUGGESTING AN AGENDA FOR TRANSFORMING ELEMENTS OF THE CTE Public Engagement and Partnership • ecognize patients as partners in transforming clinical trials. Consider virtual R clinical trial models that use mobile and web-based technologies to conduct clinical trials so that participation in a clinical trial is not dictated by geographic proximity to a trial site.
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From page 66... ...
-- Douglas Cropper, Genesis Health Systems Perspectives on developing an agenda for CTE transformation were offered by Douglas Cropper, President and CEO, Genesis Health Systems; Lynn Etheredge, Independent Consultant on health care and social policy issues, and Head, Rapid Learning Project, The George Washington University; Ronald Krall, Associate Fellow, University of Pennsylvania Center for Bioethics; James Doroshow, Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI) , NIH; and Jean Rouleau, Sci entific Director, Institute of Circulatory and Respiratory Health, Canadian Institutes of Health and Research.
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From page 67... ...
Other actions by payers also could facilitate further development of a learning health system. Just as federal "meaningful use" incentives are driving health systems nationwide to adopt EHRs more rapidly, so could Medicare be used to create incentives for providers to use EHRs for research (not just to make care more efficient and easily monitored)
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From page 68... ...
Such experimentation, after all, is more suited to a slow learning system than a rapid one. Although public and private payers are attempting to promote the use of research results and scientific evidence in clinical practice, today's clinical effectiveness evidence base is too small, according to Etheredge.
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From page 69... ...
By one analysis using ClinicalTrials.gov data, clinical trials today call for the enrollment of 1 in every 200 Americans as study participants (IOM, 2010a)
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From page 70... ...
A managed approach would help ensure that clinical research, a scarce resource, is used efficiently, with the highest priority being assigned to the most important clinical questions. Under a managed approach, central managers or key decision makers could help ensure that trials meet high scientific standards, if this central authority had authority to deny funding for proposed studies of inferior quality.
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From page 71... ...
a This box is based on the presentation by Ronald Krall, Associate Fellow, University of Pennsylvania Center for Bioethics. BOX 6-5a One NIH Official's Reflections on Collaborating with Patient Advocates I have learned a great deal about advocacy and the role of advocates.
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From page 72... ...
A national task force might be an effective vehicle for creating the organizational underpinning of CTE transformation in the United States, suggested Rouleau. Other suggestions included streamlining regulations, involving young scientists and clinicians in designing education and training initiatives, helping academic health and science centers develop research networks, integrating research data and EHRs through a new business model, promoting adaptive research designs such as cluster trials, sponsoring "research on research," and participating in international collaborations.
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5. Infrastructure: How can disease and patient advocacy networks, voluntary health associations, and other nongovernmental and
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payers; (d) disease and patient advocacy networks, voluntary health associations, and other nongovernmental and nonprofit organizations; (e)
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In pursuit of these goals, possible priorities mentioned by individual participants were 7 The NIH launched a new website, "NIH Clinical Research Trials and You," with user friendly information on what clinical trials are, why they matter, and how an individual can get involved (http://www.nih.gov/health/clinicaltrials/index.htm [accessed March 28, 2012]
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From page 76... ...
But education alone is not likely to suffice in bringing about reform. A theme mentioned several times during the workshop is that transformation of the CTE requires a shifting of the incentives that payers impose on providers of care -- namely, a shift away from procedures and volume and toward value, population health, and quality of care, as determined through scientific evidence.
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From page 77... ...
that the number of registered trials declined steadily after 2008 and, by January 2010, had fallen to the same level in place before the federal mandate to register all clinical trials took effect. Yet, no penalties for noncompliance with the mandate were issued as of February 2010 (Law et al., 2011)
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From page 78... ...
disease and patient advocacy networks, voluntary health associations, and other nongovernmental and nonprofit organizations; (e) the education and training enterprise, including academic health and science centers; and (f)
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From page 79... ...
I Advocacy • dvance public education of clinical research to engage the A networks and public as part of the CTE workforce; voluntary • evelop new and stronger consortia and research alliances; and D associations • ncrease involvement in research, such as by contributing to I study designs. Academic • atch new graduate researchers with projects that will generate M health and results, and assign them to mentors; science centers • oster research as part of health professions curricula; F and educators • uild five-tier system of workforce development (public, B community practitioners, implementers, investigators, methodologists)
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From page 80... ...
Individual workshop participants variously mentioned at least five discrete steps that could be applied to each medical treatment or intervention: (1) Results of previous experience with the treatment or intervention could be obtained (through clinical trials or observational data)
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