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Objectives:  Health decision‐makers involved with coverage and payment policies are increasingly developing policies that seek information on “real‐world” (RW) outcomes. Motivated by these initiatives, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) created a Task Force on Real‐World Data to develop a framework to assist health‐care decision‐makers in dealing with RW data, especially related to coverage and payment decisions.

Methods:  Task Force cochairs were selected by the ISPOR Board of Directors. Cochairs selected chairs for four working groups on: clinical outcomes, economic outcomes, patient‐reported outcomes, and evidence hierarchies. Task Force members included representatives from academia, the pharmaceutical industry, and health insurers. The Task Force met on several occasions, conducted frequent correspondence and exchanges of drafts …