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, as is likely for rare disease research, applicants should describe what the control group will receive and how this will be measured over the course of the study in each patient, and in multiple settings. For example, if the control group will receive supportive services, applicants should describe those supportive services and how they will be tracked during the study and accounted for in the data analysis.