Paper short abstract

This paper examines co-development of a Patient Experience Pathway for decentralized clinical trials. Drawing on engagement with patients and stakeholders, it explores how interconnected concerns around microsampling shape efforts to translate patient engagement into inclusive trial participation.

Paper long abstract

Patient and public involvement (PPI) has become increasingly institutionalized in health research through governance frameworks, funding requirements, and ethical commitments to inclusion. Yet scholars in science and technology studies (STS) have highlighted tensions between participatory ideals and the challenges of translating patient engagement into meaningful changes in research design and implementation.

This paper examines the co-development of a Patient Experience Pathway within the European context, which seeks to support more inclusive decentralized clinical trials through patient-centric microsampling technologies. The pathway is being developed through engagement with multiple stakeholders, including patients, healthcare professionals, researchers, industry partners, and regulators to gather perspectives on patient experience in decentralized trial settings.

Drawing on qualitative research and stakeholder engagement activities, we analyze the co-development process as a site where different actors articulate concerns and practical requirements related to microsampling and decentralized trials. Preliminary insights suggest that several issues such as confidence in sample validity or the need for tailored training are raised across stakeholder groups. These overlapping concerns highlight how implementing new trial models depends not only on incorporating patient perspectives but also on addressing broader clinical, technological, and organizational conditions.

By examining how these interconnected perspectives are translated into a structured pathway, the paper highlights how efforts to support inclusive participation in decentralized clinical trials involve meaningful patient engagement alongside consideration of clinical, technological, and organizational conditions. The analysis therefore points to the importance of negotiating perspectives across stakeholders to translate patient engagement into practices that can support broader and more inclusive trial participation.