The National Institutes of Health (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.”
Investigators should use the following 4 questions to determine if their study fits the Clinical Trial definition:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
If answers to all 4 questions are yes, then the study meets the NIH definition of a Clinical Trial. Investigators should take this information into consideration when choosing the correct Funding Opportunity Announcement (FOA) since the NIH recently released FOAs specific to Clinical Trials.
For more information, please see the NIH FAQs and the NIH Case Studies, which illustrate the differences between Clinical Trials and Clinical Studies.