PCORI Help Center

Will PCORI consider studies that evaluate FDA safety profiles of orphan drugs?

PCORI is interested in studies that examine both the benefits and harms of treatments for FDA-approved orphan drugs as they become more common for use in the target population. PCORI, however, is not interested in surveillance studies. Applicants must propose patient-centered comparative effectiveness research (CER) or descriptive studies that can form the basis for a CER question (e.g., describing treatments being used and outcomes). Outcomes must be those of interest to patients.

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