A comparator drug, also known as a reference drug, is a pharmaceutical product that is used as a standard of comparison in clinical trials. The use of a comparator drug helps to ensure that the results of the study are valid and that the new drug is safe and effective in comparison to the current standard of care. Sponsors are required to follow the FDA’s Investigational new drug (IND) guidelines both for the comparator drug and the investigational drug.

The comparator is typically a drug approved by the FDA that hasn’t undergone any modifications. Sponsors must specify the comparator drug, manufacturer, dosage type, and strength. An inclusion of a declaration that the use of the drug in proposed studies employing an active-control approach requires no further modification.

The selection of a comparator is among the most important aspects of research design whenever observational studies incorporate ideas of hypothetical interventions, which typically leads to a brand-new user research design. The research question and practicality concerns will determine which of the three comparative options—the active, the inactive, and the non-initiator comparator – will be used.

1.  A particular drug or group of drugs with an identical formulation and purpose to the targeted treatment is identified as an ‘active comparator.’
2.  A drug or group of drugs that are not prescribed or utilized in a similar manner as the targeted treatment is known as an ‘inactive comparator.’ When an active or inactive comparator is lacking, non-initiator comparators are frequently used.