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The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary (2002)

Chapter: Appendix V: Definitions of Clinical Research and Components of the Enterprise

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Suggested Citation:"Appendix V: Definitions of Clinical Research and Components of the Enterprise." Institute of Medicine. 2002. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10400.
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Appendix V
Definitions of Clinical Research and Components of the Enterprise

DEFINITION OF CLINICAL RESEARCH

(Clinical Research: A National Call to Action, November 1999) Clinical research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health. Clinical Research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, diagnosis and natural history of disease; (4) therapeutic interventions including development and clinical trials of drugs, biologics, devices, and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes, and cost-effectiveness; (8) epidemiology; and (9) community-based and managed care-based trials.

MAJOR COMPONENTS OF THE CLINICAL RESEARCH ENTERPRISE

Sponsors

Sponsors include private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manu

Suggested Citation:"Appendix V: Definitions of Clinical Research and Components of the Enterprise." Institute of Medicine. 2002. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10400.
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facturers, biotechnology firms, universities, private foundations, and national societies. Within the public sector the National Institutes of Health (NIH) is the largest clinical research sponsor, followed by the Department of Defense (DOD), the Department of Veterans Affairs (VA), Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control (CDC).

Research Organizations

Research organizations include academic health centers, private research institutes, survey research organizations, federal government intramural research programs, and contract research organizations.

Investigators

Investigators are the scientists performing clinical research from varied disciplines with a range of academic qualifications (e.g., MD, Ph.D., RN, DDS, PharmD).

Participants

Participants are the human volunteers, medical information and biological materials of human origin, or data derived from volunteers. Participants may have particular health conditions or may be healthy volunteers or populations at large.

Oversight Entities

Oversight entities include Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, Veterans Affairs, National Committee for Quality Assurance, and other national regulatory agencies.

Stakeholders/Consumers

Stakeholders/Consumers include health insurers, managed care organizations, health care systems, organized medicine, voluntary health agencies, patient advocacy groups, purchasers of health care, and providers of health care, public health systems, and individual consumers.

Suggested Citation:"Appendix V: Definitions of Clinical Research and Components of the Enterprise." Institute of Medicine. 2002. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10400.
×
Page 101
Suggested Citation:"Appendix V: Definitions of Clinical Research and Components of the Enterprise." Institute of Medicine. 2002. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/10400.
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Page 102
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In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore:

  • What do purchasers and payers need from the Clinical Research Enterprise?
  • How have current efforts in clinical research met their needs?
  • What are purchasers, payers, and other stakeholders willing to contribute to the enterprise?

This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

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