PCORI Help Center

What is the minimum recommended sample size for this PFA?

PCORI does not require a minimum project sample size because this will be up to the investigative team and will vary depending on the specific research question and study design. However, as noted in the PFA, "The studies must be relatively large, in part to be able to demonstrate differences in comparative clinical effectiveness in the study arms, but also to allow adequate power to detect the potential differences in treatment responses by patient clinical characteristics of interest."

We note that estimating sample size sufficient to provide adequate power for Heterogeneity of Treatment Effect (HTE) analysis can be challenging and typically requires expert statistical consultation. Other potential challenges to achieving target sample size (e.g., recruitment feasibility, unintended crossover in randomized controlled trials, and anticipated attrition) should also be factored into sample size considerations as appropriate.

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