The Patient Perspective: Involvement of Patients in Translational Research and Clinical Investigations

This session will emphasize the crucial role of the patient in translational research and clinical investigations, particularly in the area of Early Feasibility Studies (EFS). EFS play a vital role in the evaluation process for the safety and performance of medical devices in their initial stages of development; however, such success also depends on effective patient engagement. Drawing from extensive discussions with the Patient Advisory Group (PAG) of the IHI-funded project HEU-EFS and insights gathered from various patient consultations, we will explore how integrating patient perspectives can significantly enhance the design and execution of EFS. Active patient involvement not only enriches the research process but also ensures that studies are aligned with the real-life experiences and needs of patients. We will present recommendations aimed at addressing gaps and barriers that currently impede effective patient engagement of patients across various aspects of clinical trials, from communication challenges and lack of awareness about participation opportunities to lack of support systems during trials. The recommendations we put forward will emphasize strategies for facilitating effective dissemination of information and communication between researchers and patients, ensuring access and understanding of information. Moreover, we will highlight the need for creating an environment of collaboration in which patients are made to feel valued partners in research and relevant decision-making processes. By fostering open dialogue and encouraging feedback throughout the study process, researchers will be able to gain insights from real-world experiences. Exploring a wider angle, we will also highlight the benefits of high-level engagement of patients to help shape policy recommendations and regulatory decisions for innovations such as EFS. Attendees will gain insights into best practices and strategies for engaging with patients. By prioritizing patient perspectives in translational research and clinical investigations, we can create a more inclusive approach that seeks to advance both scientific knowledge as well as contribute to better treatment and care for patients. This session will therefore prepare key stakeholders, such as researchers, industry, and medical professionals, to engage meaningfully with patients, ensuring that medical technology innovations benefit from patients' unique perspectives while also truly meeting their needs.