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Does PCORI expect the study to have individual randomization of each participant, or could a cluster randomization design be used?

While PCORI does not wish to be directive in the applicant’s study design, we do not consider cluster randomization to be the most suitable design for the research question envisioned under this targeted PFA. Should an applicant propose a cluster randomized trial, it should be well justified as to why this approach is preferable to individual randomization. In addition, given that cluster randomized trial designs feature added complexity and reduced statistical precision, and consequently require more participants, the proposed study should be appropriately powered to allow for such an approach.

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