Patient-reported outcome claims in European and United States orphan drug approvals.

J Mark Access Health Policy · 2018 · PMC6225506 · PMID 30425804

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a decreasing trendno p-value reported

Whereas a decreasing trend in PRO claims was reported for FDA approvals from 2006 to 2015 [ 7 , 10 ], it is unknown if a similar trend occurred at the EMA.

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Quoted from the open-access full text in Europe PMC under the licence the publisher applied. The sentence is reproduced exactly as published; the emphasis is ours.