Enhancing clinical trials design by involving and integrating patient-input through a novel approach: Human factors Clinical Study Experience Simulation

<bold>Aim:</bold> There is an increased focus to incorporate patient perspectives and needs into clinical development. The objective of this human factors (HF) research is to gather patient perspectives on the Phase 2b randomized clinical trial (RCT) design of a novel Idiopathic Pulmonary Fibrosis (IPF) drug in order to enhance patient experience and reduce treatment burden. <bold>Methods:</bold> HF Study conducted in the United Kingdom and the United States with IPF patients (PT) (N=11) and pulmonologists (PL) (N=11). PT: individual four-hour in-person simulation interviews of multiple clinical study settings created to provide an immersive experience and journey. PL: interviews to provide a patient-advocate perspective. <bold>Results:</bold> The study gathered perspectives on the drug description, RCT design structure, recruitment, consenting and screening processes, treatment period, and study completion processes. Participants’ reactions to the RCT design were positive (78%). The remaining participants (22%) focused on treatment burden (e.g., route of administration, dosing regimen). Different PT vs PL needs priorities were detected. Interest (60%), trust (16%), and optimism (16%) were the top three emotions associated to RCT description. More than 50 recommendations for RCT design and process improvements were gathered to drive the patient centric approach in the next RCT. <bold>Conclusion:</bold> Results showed emotional and psychological aspects of people living with IPF and provide information on their expectations in terms of new potential treatments and supporting services laying the foundation for a new methodology of developing RCT designs tailored around patient needs.