Head-to-Head Study (H2H)

Clinical trial design in which medicines are evaluated against each other.  In general, a medicine that has not been approved is tested against one that is already on the market.  Ethically, the investigational medicine must be compared directly to an existing standard of care – ensuring that a poorly efficacious drug is not compared to the new treatment.  In some circumstances, an investigation drug is added to a standard of care which is then compared to the efficacy of the standard of care alone.