» Clinical Trials

NIH now 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.”

If the answer is “Yes” to all four of the following questions, the clinical study would be considered a clinical trial by NIH:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

NIH also provides this additional guidance that indicates that if the answers to the 4 questions are yes, the study meets the NIH definition of a clinical trial, even if…

  1. The Investigator is studying healthy participants.
  2. The study does not have a comparison group (e.g., placebo or control).
  3. The study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug.
  4. The study is utilizing a behavioral intervention.

If your study meets the definition of clinical trial it will need to be registered in ClinicalTrials.gov.  Contact the Office of Research Integrity for more information. 

Click here to view the overview of the broader definition.