Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix D: Discussion Paper: The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation
Appendix D: Discussion Paper: The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation
Pages 133-160
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and the health care delivery system has been sub ject to increasing amounts of stress. During this period, the CTE has primarily focused on process improvement, seeking to create and maintain procedures and data systems that can satisfy a regulatory environment concerned with specific research procedures.
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The scope and pace of change in the overall health system will only increase as we enter the next decade, exacerbating the undesirable separation of research and practice. There is thus an urgent need to develop policies that will mitigate current stresses and increase CTE efficiency and effectiveness by expeditiously forming a deliberate plan to align the CTE and the emerging health care delivery system.
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This paper provides a roadmap for integrating the clini cal trials and health care delivery systems in ways that will improve the efficiency and effectiveness of both. Current Status of the Clinical Trials Enterprise The passage of the Food and Drug Administration (FDA)
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or major chronic diseases that may have a different outcome or treatment effect with different genetic backgrounds or patterns of clinical care than those found in the United States. Offshoring is a concern because it diminishes synergies between basic and clinical research that are vital to translational research, and because it weakens the interface with industry that speeds advances in drugs and devices made available to the American public.
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The IHS and/or affiliated group practices serves as the locus of medical homes and accountable care organizations. Integrated health care organizations and their affiliated service organizations either employ or contract with a substantial majority of health care providers, including physicians, nurses, advanced-practice nurses, physician assistants, clinical social workers, and psychologists.
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Every health care delivery site is a learning site, providing continu ing health education (CHE) that includes point-of-care reminders, links to clinical practice guidelines, and other online resources.
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While the nation has yet to reach this envisioned state of health system integration and effective use of the EHR, the implementation of national health care reform legislation and the efforts of organizations to display their accountability for health care outcomes and costs will likely bring us closer to this stated vision. PART II: THE FUTURE OF CLINICAL RESEARCH Controlled clinical trials are the essential cornerstone of modern evidence-based medical care and health practice.
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in all societies. A major problem in the field of clinical research is the current absence of a standard ontology that adequately encompasses its activities, rendering it difficult to characterize the state of the enterprise.
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As the clinical research ontology develops, better classification will be key to accurately measuring the progress of the enterprise by comparing the same types of studies and methods over time. Currently, more than 330 clinical trials are registered every week with the ClinicalTrials.gov registry, which now contains data on more than 110,000 studies.
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public. Although there appears to be variation among socioeconomic and ethnic groups, the public in general places high value on both research in general and clinical research in particular.
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. Because of these challenges, we believe that the CTE can and must be improved and integrated with the evolving health care delivery sys tem as part of an essential evolution toward the learning health system envisioned by the IOM (2007)
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An example of the second type of efficacy study would be a trial of a new treatment for seasonal allergies, in which there is no reason to burden the health care delivery system with people who can elect to participate in a trial of a less serious condition. While this type of study could be done in primary care practices, it might also be done most efficiently in stand-alone research centers divorced from the pressures of the practice environment.
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. The Community Engagement Lab Many interventions that have a potentially great impact on health either do not involve the health care delivery system or do so only peripherally.
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and the development of a common informatics infrastructure, with core technologies available for assessing systems biology and linking phenotypic information with genomic and physiological data. The Traditional Lab should be rejuvenated by linking more efficient traditional research-site functions with the evolving health care delivery lab.
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Expanding the base of clinical research to include many if not most of the non-academic IHSs will result in important contributions to the vitality of service-delivery systems and to the richness of professional practice in all of the participating entities. In addition to nurturing clinician research, these Health Care Delivery Laboratories will facilitate the translation of research from the bedside to community practice.
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Incorporating research as a core element of a health system's mission, objectives, and strategies will enhance the system's stature and attract political, community, and financial support. It will also expedite the recruitment of practitioners and other employees who aspire to be associated with an organization at the leading edge of health care development.
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The national goal of expanding Health Care Delivery Labs will be enhanced if the research initiatives of community-based practitioners in integrated delivery systems lead to those practitioners being recognized as "clinical research associates," thereby positively differentiating them from their peers. Participation in clinical trials and other research can be a focus of
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These questions reside largely in the domain of health services research (HSR) , which has been defined as "a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing and outcomes of health care services" (IOM, 1995)
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Some of the savings enabled by continuous quality improvement in health care could also lower the costs of care and premiums paid by patients, or at the least moderate their continued increase. The authors developed this paper in the context of the IOM Forum on Drug Discovery, Development, and Translation's 2-year effort to assess the current status of the clinical trials enterprise and to put forward a plan to assure a robust and optimal future for clinical research.
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2009. Clinical research sites -- the underappreciated component of the clinical research system.
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2008. Evidence-Based Medicine and the Changing Nature of Health Care: 2007 IOM Annual Meeting Summary.
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2008. Projections of the population by selected age groups and sex for the United States: 2010 to 2050 (2008 projections)
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(1.9) Basic science 1,882/75,778 1,882/75,198 1,735/38,199 (2.5)
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(1.8) Lead sponsor classification, n/N (%)
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edu/sites/informatics. mc.vanderbilt.edu/files/Stead-AMIA2010-Presentation.pdf duplicated from new S-3.eps in job R01152 (accessed January 6, 2012)
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Arrows below each figure depict the clinical research continuum from basic research to R02159 Figure D-2 vector, editable color
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2003. Central challenges facing the national clinical research enterprise.
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