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In this Chapter, Patient Voice in Clinical Trial Programs in Industry, we argue that the Life Sciences industry must adapt if they are to succeed and make medicines with (rather than just for) patients. Those companies able to deliver medicines and interventions that reflect patient priorities and needs as identified through meaningful patient engagement will ultimately prosper. Regulatory bodies and initiatives established to promote patient engagement are providing incentives and platforms for multiple stakeholders to embed the patient perspective in product development. Collaborative approaches are providing practical guidance and frameworks for capturing patient insights. Increasingly, patients’ experiential knowledge is being incorporated into clinical research – including in real-world studies – facilitated by the availability of technology. Authentic patient engagement should strive to ensure representation of the whole population and care continuum. If the patient voice is to be respected in clinical trials programs, open, two-way communication and education will be essential.

Background Patient engagement is an essential aspect in the research/development of biopharmaceutical products and disease management. Improving the lives of patients requires a deep understanding of their medical conditions, experiences, needs and priorities. However, a consistent definition of patient centricity is lacking. A series of initiatives was conducted to define patient centricity and its important principles impacting the biopharmaceutical industry. Methods Interviews, questionnaires and literature reviews were conducted involving key stakeholders to initially identify issues of importance to patients, healthcare providers and payers. Subsequently, two identical workshops which included 22 patients/carers created a definition of patient centricity and the healthcare values important to patients/caregivers. Outputs were tested in a validation exercise involving patients in predominantly US (n=470) and European (n=703) patient forums. Results Initial research provided deeper understanding of patient needs and key topics of interest that were used to cocreate a definition of patient centricity and 10 associated principles of importance to the biopharmaceutical industry. Wider testing of these outputs among predominantly US/European patient communities confirmed their validity. Patient centricity should be defined as ‘Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family’. Important principles for patients focused on education/information, cocreation, access and transparency. Conclusions The development of a consistent definition of patient centricity and its associated principles provides an opportunity for biopharmaceutical companies to adopt and use these as a reference point for consistent patient engagement throughout the product life cycle.