How to determine if the proposed study is a clinical trial?

To encourage advances in the design, conduct and oversight of clinical trials, the National Institute of Health (USA) revised the definition of Clinical Trial in 2014 as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (that includes placebo) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes."

A CRO or Sponsor when submitting IND for a clinical trial should ensure the answers to following 4 questions are yes. Misclassified clinical trial application (or an IND) will be withdrawn.

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?

If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…

- You are studying healthy participants.

- Your study does not have a comparison group (e.g., placebo or control), or has a single arm.

- Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug.

- Your study is utilizing a behavioral intervention, or measuring intent to change behavior.

- Only one aim or sub-aim of your study meets the clinical trial definition.

- Your study is no more than minimal risk.

Note:

- Studies intended solely to refine measures are not considered clinical trials : These are research projects where the primary goal is to improve the quality of data collection tools like questionnaires or assessment scales without actively testing an intervention.

Example: A researcher might conduct a study to test different wording options on a depression questionnaire to ensure it accurately captures the range of symptoms experienced by patients.

- Studies that solely involve secondary research with biological specimens or health information are not clinical trials: Secondary research usually utilizes existing data or biological specimens that were collected for a different purpose previously, without any new interventions with subjects.