Comparator is a well-established concept in clinical trial design and appears frequently in:

  • ICH guidelines (especially E6, E9, E10),
  • trial protocols,
  • statistical analysis plans,
  • regulatory submissions,
  • clinical study reports.

It’s also a term that junior CRAs and investigators sometimes misunderstand, equating it only with an active control.

A glossary entry can clarify that a comparator is broader and may include:

  • placebo,
  • active control,
  • standard of care,
  • no treatment (in some designs),
  • historical or external control (depending on context).