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



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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

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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.