Defining meaningful change for COA scores

With a strong understanding of regulatory expectations and our expertise as measurement scientists, Adelphi Values employ a range of qualitative methods to explore which concepts would be most meaningful to change, as well as the level of change on a clinical outcome assessment (COA)/anchor assessment that would be meaningful and why. Investigations of meaningful change are commonly explored independent of clinical trials based on hypothetical changes, but are increasingly being used within in-trial/exit interviews which provide the opportunity to explore actual change experienced due to the investigational treatment.