Literature and COA instrument reviews

Qualitative literature reviews

Reviews of existing qualitative evidence can provide an initial understanding of health experiences that result from a disease/condition, including the symptoms and impacts that are important to patients and/or caregivers. These findings may be summarized in a preliminary conceptual model and used to inform the initial evaluation and selection of COA measures.

COA instrument reviews

Instruments are identified and critically evaluated in the context of current scientific standards and regulatory expectations. Reviews may focus on face and content validity, measurement properties, prior use in clinical studies and regulatory claims or feedback for reviewed measures. Evidence is ultimately used to determine whether measures are fit for purpose and to identify potential evidence gaps that may be addressed by future research.

Gap analysis

By mapping existing COA instruments against conceptual models or target product profiles, we can provide recommendations on appropriate COA measurement strategies to capture the patient experience in clinical studies.

Reviews of COA data

Reviews of existing COA data from prior research can provide insights into the performance and appropriateness of a COA (e.g., ability to detect change over time) for the intended context of use. Consideration of available COA data for competitor medical products that are approved or currently in development can also be used to understand opportunities for product differentiation.