Why involvement remains fragile: a qualitative comparison of principal investigators’ and patient organisations’ perspectives in Italy

Abstract

Background Patient Public Involvement is increasingly promoted to enhance the relevance, feasibility, and ethical grounding of clinical research, particularly in oncology, where trials can be demanding, and quality-of-life trade-offs are substantial. Despite this, involvement often remains fragile and inconsistently embedded in routine trial practices, especially where shared operational standards are limited. This study examines why involvement remains difficult to institutionalise in Italy, that is, to move from informal, individually dependent practice toward formally recognised and stable roles within research routines, by comparing perspectives from principal investigators and patient organisation representatives. Methods We conducted 34 semi-structured interviews with principal investigators and patient organisation representatives and analysed the data using inductive thematic analysis. Interviews were audio-recorded with consent, transcribed verbatim, and analysed using an inductive thematic analysis. Through iterative coding and thematic clustering, recurring barriers and areas of convergence and divergence between stakeholder groups were identified. The resulting themes were subsequently organised into four cross-cutting dimensions—cultural, organisational, operational, and institutional—to support comparison and reporting. Results Participants in both groups described a shared set of interrelated barriers but interpreted and prioritised them differently. Cultural barriers centred on tensions around expertise, authority, and the perceived legitimacy of experiential knowledge in trial design. Organisational barriers included fragmentation within the patient organisation landscape and misalignment of priorities between scientific endpoints and patient-relevant concerns. Operational barriers reflected workload pressure, limited integration of involvement into trial workflows, and asymmetries in language and expertise that constrained informed participation. Institutional barriers included discontinuity, limited feedback to patients and organisations, and the absence of clear guidance on when and how to engage patients consistently. Together, these factors contributed to involvement being late, episodic, and dependent on individual initiative rather than routine practice. Conclusions Involvement in Italian oncology research remains fragile because multiple barriers intersect across culture, organisation, operations, and institutions, rather than acting in isolation, while stakeholders often hold different assumptions about roles and value. Strengthening involvement requires more explicit operational guidance, dedicated resources, and shared capacity-building to support earlier, more consistent, and more sustainable collaboration. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-026-00947-9. Abs1 Patients and patient organisations are increasingly encouraged to contribute to clinical research so that studies better reflect real-life needs and are easier, fairer, and more relevant for those taking part. This is especially important in cancer research, where treatments and clinical trials can be long, complex, and disruptive to everyday life. However, in Italy, patient involvement is still not routine in research and often depends on individual researchers' willingness. In this study, we explored why this happens by interviewing two groups: principal investigators, who design and lead clinical studies, and representatives of patient organisations, who support patients and often interact with research teams. We asked about their experiences and about the main difficulties that make patient involvement hard to achieve in practice. Both groups recognised many of the same problems, but often understood them differently. Some barriers are linked to culture and professional roles, including uncertainty about who should influence research decisions and how much value should be given to patients’ lived experience. Others are organisational and practical, such as fragmented collaboration, lack of time, heavy workloads, and limited resources. Communication is another challenge, especially when research is presented in highly technical language that non-specialists find difficult to understand. There are also broader system-level problems, including a lack of continuity, limited feedback to patients and organisations, and no clear shared guidance on how involvement should happen. Overall, patient involvement remains fragile because these barriers interact with one another. Clearer guidance, dedicated support, and shared training could help make involvement earlier, more consistent, and more meaningful. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-026-00947-9. Abs2 plain-language-summary