COA Dossier development
COS has authored numerous evidence dossiers to defend a COA’s inclusion
in the label and defended them at the FDA and EMA.
Increasingly, the FDA and EMA are requesting an evidence dossier to defend a COAs’ inclusion in the label. The dossier outlines in detail:
- how the content of the measure was developed
- the strength of the measures’ psychometric properties and,
- importantly, definition of a meaningful change threshold.
In addition to this validation history there is a need to provide details about how the measure was implemented in the clinical trial(s) e.g.:
- rigour of translation process
- adjustment for multiplicity in the endpoint hierarchy
- training for sites on how to administered the measure.