How well-established should the intervention be?

PCORI expects the efficacy or effectiveness of each intervention to be known. If the efficacy or evidence base is insufficient, then data need to be provided to document that the intervention is used widely. Furthermore, this PFA focuses on the testing of active comparators. Projects aiming to develop new interventions that lack evidence of efficacy or effectiveness will be considered out of scope. However, adaptation of interventions is allowable with evidence of the adaptation’s effectiveness. Applicants should propose interventions and comparators that have evidence of prior efficacy or are in use within appropriate settings and populations. Justification of prior efficacy or use could include, but is not limited to, findings from pilot studies, clinical trials, literature reviews, clinical practice guidelines, and standardized usual care protocols. If usual care is included as a comparator, it must be well justified, well defined, and sufficiently measured.