Developing Personalized Clinical Outcome Assessments

In recent years, patients, advocates, researchers, regulators, and other stakeholders have highlighted the importance of engaging patients more directly in medical product development and the regulatory review process. A key focus of these efforts has been advancing the science of patient input: identifying rigorous, systematic approaches to incorporating patient perspectives in medical product development, developing patient centered outcomes, and applying innovative drug development tools to capture data on those outcomes. A critical component of this advancement has been the development and implementation of well-defined and reliable clinical outcome assessments (COAs), which measure how a patient feels, functions, or survives and determines whether or not a drug provides clinical benefit.