Patient reported outcomes in clinical trials and practice with older patients

Abstract

Patient-reported outcomes (PRO) retrieve information directly from the patient on their perception and experience with a therapeutic intervention. PRO concepts are developed case-by-case for their specific application. They are being used in clinical research and clinical practice to support a variety of different purposes like labeling claims, comparative effectiveness research, patient communication, therapeutic decision making, and health policy development. Some remaining challenges with PRO measures are being addressed and will continue to drive the implementation into research and clinical practice over the coming years. Applying and integrating PRO measures, especially in older patient populations, early on in the development of a new drug product can provide the opportunity for enhanced drug product design, including additional label claims.