We act as a bridge between the psychometricians who develop instruments and the clinical trialists who design and analyse studies. We review an instrument’s psychometric properties and help define the endpoint your clinical study will use.
Endpoints based on patient-reported outcome (PRO) or other clinical outcome assessment instruments need to line up with the study’s objectives. PRO endpoints are usually more complex than other assessments, so their development has to take into account:
We help analyse and interpret study results and advise on how best to present findings to FDA and other regulators. We also review PRO dossiers and regulatory submissions that include PROs, to spot gaps in the information provided.