Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research.

The Patient-Centered Outcomes Research Institute (PCORI), created and funded by the Affordable Care Act, is charged with bringing the patient perspective to clinical research design and the outcomes that are studied. However, there is no consensus definition of "patient-centeredness" or "patient-centricity." This paper distinguishes between the terms and describes an infrastructure for supporting the concept of patient-centricity. The patient's role needs to be described in a way that makes it feasible to implement health care delivery and support parameters to conduct clinical research over a sustained period of time. The authors propose the use of a structured Practice-Based Clinical Research Network to perform patient-centered outcomes research consistent with the requirements of the pharmaceutical sector in a safe, ethical, and effective manner and congruent with the principles of Good Clinical Practice (GCP).