The objective of this research is to evaluate whether the 2009 FDA PRO Guidance leads to development of similar measures when followed by different researchers in the same disease. Psoriasis was selected as a case study, because two companies recently published patient-reported outcome measures to assess the severity of psoriasis-related symptoms: the Psoriasis Symptom Inventory (PSI) and the Psoriasis Symptom Diary (PSD).
For two companies the FDA PRO Guidance leads to similar but different measures
A case study in psoriasis
Mordin, M., Brown, T., McLeod, L., DeMuro, C., & Gnanasakthy, A. (2015). For two companies the FDA PRO Guidance leads to similar but different measures: A case study in psoriasis. Value in Health, 18(3), A111-A111. https://doi.org/10.1016/j.jval.2015.03.653
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