Will PCORI consider funding a rare disease study that includes a usual care group?

PCORI prefers studies comparing at least two active interventions. If usual care is included as the comparator in the control group of the study, applicants should describe what usual care entails and this will be measured over the course of the study in each patient, and in multiple settings, if applicable. Specifically, the investigator is required to: (1) justify why usual care is the appropriate comparison; (2) describe usual care in the context of broader clinical settings (i.e., whether significant variables exist); and (3) describe how usual care will be measured over the course of the study in each patient.