Clinical Trial Definition
NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. These interventions include drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
See the NIH Definition of a Clinical Trial for further details, including case studies and frequently asked questions (FAQ's).
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NIH & NIDCR Expectations for Researchers Conducting Clinical Trials
NIDCR adheres to NIH-wide policies for investigators conducting clinical trials. To learn about new NIH initiatives, policies and resources related to clinical trials, see the information posted by the NIH Office of Extramural Research (OER) and the NIH Office of Science Policy (OSP).
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Implications for Social & Behavioral Trials
The NIH clinical trial policies are applicable to social and behavioral studies that meet the NIH definition of a clinical trial. Please visit the Office of Behavioral and Social Sciences for more information.
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Applying for Funding
NIDCR has specific Funding Opportunity Announcements for clinical trials found at:
You may also contact your NIDCR Program Official for more information.
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