Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

Good measurement principles form the foundation for clinical outcome measurement. Investment in measurement will ultimately benefit people with diseases, drug developers, clinical trialists, and regulatory authorities. This session will provide an overview of the comprehensive process of creating and implementing a new outcome measure or modifying an existing instrument. The development of a patient-based, clinical outcome measure that will support a labelling claim requires advance planning in the early phases of product development. Establishing the context of use and planning the protocol for qualitative research that thoroughly explores the conceptual basis for measurement are fundamental. This session emphasizes the importance of identifying what is meaningful to be measured based on the context of use for measurement, getting the content right, and finally, ensuring that the measure is meaningful and interpretable.