DOI: 10.6084/m9.figshare.30927132
title: Patient perspectives of patient engagement in medicine development: a qualitative study

description: Patient engagement (PE) is increasingly recognized as an essential component of medicine development, yet there remains limited empirical evidence on its value from the patient perspective. Existing literature points to benefits such as empowerment, improved trial design, and greater acceptability, but challenges around communication, authenticity, and sustainability persist. This study explored the perceived value, challenges, and strategies for effective PE from the perspective of patients, carers, and patient advocates involved in medicines development. A qualitative study was conducted using semi-structured interviews on Microsoft Teams. Participants were recruited via LinkedIn and academic networks if they had lived experience of a health condition, caregiving responsibilities, or advocacy roles and had engaged with the pharmaceutical industry. Twenty-two interviews were conducted online between 23 April and 26 November 2024, recorded, transcribed, and analyzed using reflexive thematic analysis. Six overarching themes and 23 sub-themes were identified covering participants’ understanding, motivations, initiatives, value, challenges and strategies for being involved. Engagement was valued for enhancing clinical trial outcomes, personal empowerment, and community support. Challenges included structural barriers, tokenism, lack of feedback, and inconsistent practices across companies and patient organizations. Strategies to improve PE emphasized clear communication, simplification and formalization of processes, greater inclusivity, capacity building, and stronger alliances among advocacy groups. Participants also highlighted the need for fair compensation and balancing regulation with meaningful involvement. Patients perceive PE as transformative when authentic, inclusive, and supported by transparent communication. Addressing structural inconsistencies, recognizing diverse patient identities, and prioritizing relational over transactional approaches are critical for embedding meaningful and sustainable PE in medicine development. This is a summary of a study about the impact of engaging patients in the research and development of new medicines which is becoming more common, but how this is done and how helpful it is varies a lot amongst stakeholders. The focus of this study was on patients, caregivers and patient advocates. In this study, 22 people who have lived experience of a disease condition, are caring for someone with a disease condition or advocate for patients across Europe and North America were interviewed to understand their views on their involvement in the research and development of medicines. The main questions the researchers wanted to answer were: 1. Participants views on patient engagement and its perceived benefits The participants told us that their engagement in research and development felt empowering to them. They also value the patient community that these engagement creates supporting and learning from each other. They also believe that their involvement is good for business as it leads to the development of medicines that meet their needs. 2. Participants views on current barriers to patient engagement. The participants mentioned challenges such as lack of feedback and adequate communication between the developers and patients. There is also lack of capacity to be involved, including very complex process of becoming part of the patient advisory group. Sometimes the meetings are virtual hindering accessibility and also very diverse ways of doing things across companies. Despite these issues, participants identified opportunities for improvement, including training, better communication, greater unity amongst patient advocacy groups and broader patient representation. Overall, this research showed that better communication, capacity-building, simplified processes, more representation and consistent approaches are needed to demonstrate the true value patients bring to medicine development.