Why are studies called investigational?

The term "investigational" is used frequently in our advertisements to describe the study medications beind evaluated. Investigational refers to a drug or device that is under clinical evaluation. This means it is studied in human populations but not approved for use by the general public. A research study to gain more information about an approved drug would require that drug to be called investigational while under study. It also can mean an approved drug that is being evaluated for use in a non-approved manner, like a:

  • change in dosage
  • route of administration or
  • indication.

Common examples of a change in indication would be:

    • an antidepressant that is evaluated for its ability as an anxiety medication
    • an antidepressant that is evaluated to treat hot flashes
    • a vaccine for older adults that is being studied in a different age group.