Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development

Background:Recently, drug development companies have sought out patient feedback to improve overall drug development. However, characterization of the overall impact and return on engaging with patients have not been determined.Methods:The Drug Information Association (DIA), the Tufts Center for the Study of Drug Development (Tufts CSDD), and 17 other stakeholder organizations collaborated on a study to (1) quantify and define patient-centric initiatives (PCIs) utilized in clinical research and development and (2) to define evidence-based metrics and performance indicators that demonstrate return on engagement (ROE) of specific PCIs. We conducted a literature review, industry surveys, and in-depth interviews to determine and measure the impact of adopted PCIs.Results:We identified and defined 30 PCIs used to engage with patients. We analyzed 121 case studies and created a comprehensive list of metrics assessing overall return to the organization and to patients. Advocacy Group Support and Involvement, Con...