PURPOSE: There is increasing interest in engaging patients in all aspects of health research and in the use of information from clinical outcomes assessments (COAs) in clinical practice, drug development, reimbursement decisions and health care performance evaluations. Patients are key stakeholders whose involvement in COA development as research participants has been acknowledged as good scientific practice. Recently, however, the perspective has shifted towards broader patient engagement in formulating research questions, developing study designs, improving implementation, informing the assessment of drug benefits and risks, and enhancing results’ interpretation. Since 2012, the FDA has coordinated a series of meetings to hear from patients and their care partners about the impact of their disease. The input from these meetings has highlighted that patients’ perspectives are key to identifying and measuring the treatment benefits and burdens that matter most to patients and should be considered in the evaluation of drugs. This workshop will discuss approaches to engagement of patients in COA development, implementation, interpretation and dissemination in health care research.  DESCRIPTION: Patient engagement will be explored from multiple perspectives by encouraging insights from the audience following examples from individual presentations. The presentations will focus on methods and challenges associated with: 1) patient engagement on collaborative projects that include industry, patient advocacy groups, and academia; 2) the current FDA initiative for obtaining patients perspective on disease experience and treatment and plans for guidance on methodologically sound pragmatic approaches to incorporating the patient’s perspective; 3) sponsor organizations’ strategies to facilitate patient engagement as research advisors in contrast with seeking their input in standard endpoint development research; 4) a recent celiac disease research summit that brought together patients and other key stakeholders to establish a long-term patient-centered research agenda. Each speaker will share their experience, highlighting benefits and lessons learned and discuss recommendations for patient engagement with the audience.