The Patient Motivation Pyramid and Patient-Centricity in Early Clinical Development

Background It is increasingly recognized that patients should be involved in the design of clinical trials. However, there is a lack in agreement of what patient-centricity means. Methods In this article a Patient Motivation Pyramid based on Maslow's theory of human motivation is introduced as a tool to identify patient needs. This pyramid is used to make a comprehensive overview of options to implement patient-centric trial design. The Pyramid with the described options can help to identify patient-centric activities suitable for a given drug development. The current article further describes potential benefits of patient-centric trial designs with an emphasis on early clinical development. Especially in early clinical development during which trials have many assessments per patient, and the safety and clinical efficacy are uncertain, patient-centric trial design can improve feasibility. Finally, we present three case examples on patient-centric trial design. The first example is seeking patient input on the trial design for a First-in-Human trial which includes patients with Immune Thrombocytopenic Purpura. The second example is the use of a video link for home dosing. The final example is the use of digital medicine in a trial in heart failure patients. Results A comprehensive overview of patients' needs can be accomplished by building a Patient Motivation Pyramid as a tool. Patient input can lead to improved endpoints, improved feasibility, better recruitment, less dropout, less protocol amendments, and higher patient satisfaction. The use of digital medicine can lead to a trial design with much less visits to the clinical research center in early clinical development, and in a later development phase even to a complete virtual trial. Conclusion We recommend using the Patient Motivation Pyramid as structural approach for identifying elements of patient-centricity. Secondly we recommend to start using patient-centric approaches in an early phase of the medicine's lifecycle.