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The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. Sponsors currently engaged in drug development programs appreciate and leverage the added value of patient-reported outcome (PRO) data. They no longer ask if PROs should be collected, but what phase to begin PRO collection.
This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture. The intention of this issue to provide clinical teams with industry data that can refute the presumption that paper methods are cheaper than ePRO.