Establishing content validity of patient reported outcome (PRO) measures is a critical stage in establishing the measure’s utility.
In the FDA Final Guidance to Industry in 2009 the importance of establishing the content validity of a PRO was stressed. More recently members of the Study Endpoints & Label Development (SEALD) division of the FDA presenting at the 45th annual meeting of the Drug Information Association emphasised the importance of content validity as an important qualitative measure.
While there is a range of qualitative methodologies to derive PRO content including, Grounded theory, case study and ethnography, we believe there is scope to look at the more innovative approaches in identifying relevant PRO content.
In tomorrow’s post we will discuss the viability of co-creation as a method to derive valid PRO content.
Categories: Patient reported outcomes