Patient-centered drug development and the Learning Health System.

Patient-centered drug development (PCDD) is a shift in the way that drugs are developed, systematically incorporating patient participation in all stages of medicines development. The more the research sector understands the needs and values of patients, the more effective and efficient it can be in bringing meaningful drugs and evidence to patients and providers. In this paper, we describe PCDD, provide examples of PCDD work across the phases of drug development, and discuss the challenges to making PCDD systematic. We describe how the developing Learning Health System will enable PCCD: we believe that the Learning Health System will address PCDD barriers by connecting stakeholders, enabling the more efficient flow of data, information, and evidence in the health ecosystem, and by providing governance for the connected ecosystem.