We are the bridge between psychometricians who develop instruments and clinical trialists who design and analyze studies. We consider the psychometric properties of an instrument and guide the development and definition of the endpoint that a clinical study will use.
An endpoint arising from a patient-reported outcome instrument or another type of clinical outcome assessment instrument needs to align with the study objectives to get the best possible results. We recognize this sounds familiar because it’s the process you go through when designing studies that use other types of assessments. However, PROs are usually more complex. Endpoint development must consider other factors like timing of visits, timing of assessments, and floor and ceiling effects. Statistical analysis plans must also consider multiplicity concerns presented by PRO endpoints.
We help you analyze and interpret study results and recommend how to present findings to FDA and other regulatory agencies. We review PRO dossiers and regulatory submissions that include PROs and identify information gaps.