Elizabeth J. Clark

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.

Patient involvement in pharmaceutical industry-sponsored publications is a rapidly evolving practice. It is supported by industry guidelines, but currently inconsistent across organizations. This study aimed to qualitatively map the landscape of current practices and gaps in patient involvement in peer-reviewed journal publications of pharmaceutical industry-sponsored research, and to define the specific roles and activities in which patients are involved. This qualitative, patient-led study was conducted using semi-structured interviews with purposively sampled experts in patient engagement and publications, including patients. Interviews were conducted online, transcribed, and thematically analysed. Landscape elements were visually mapped, and themes were generated through an inductive and experientially situated thematic analysis. Interviews were conducted with 20 participants recruited globally, with a majority from the United Kingdom. Participants represented diverse stakeholder categories and reported patient involvement across all stages and aspects of the publication lifecycle, with patients both as external consultants and as professionals working within the system. Five overarching themes and 20 sub-themes were identified, including: patient identities and roles; principles and values; processes and practices; variations over time and across organizations; and impact. Significant gaps were identified in consistency, quality, and scale, for example including gaps in infrastructure barriers and diversity. Patient involvement in pharmaceutical publications is actively happening across the publication lifecycle and is rapidly growing and evolving. This study provides an evidence base via a qualitative mapping of the experiential landscape and highlights the need for established best practices to support consistency and quality in meaningful patient involvement in publications.

Patient engagement (PE) is increasingly recognised as a critical component of clinical research and pharmaceutical development. However, its implementation remains inconsistent, and evidence of its impact limited. This study explored pharmaceutical professionals' perspectives on the value, challenges, and facilitators of PE in medicine development. Twenty-eight industry professionals from Europe and North America were interviewed online (November 2023-May 2024). Data were analysed using inductive reflexive thematic analysis. The result showed that while PE is acknowledged for its potential in enhancing trial design, patient recruitment and retention, enhancing data quality, regulatory success and market access-the evidence demonstrating its impact in these areas are still limited. Key challenges highlighted were the lack of standardised ways for assessing PE's value, limited access to patient organisations in some regions, and disparities in regulatory requirements that complicate global adoption. Additionally, practical barriers-such as time, resource constraints, and cultural differences, hinder the implementation of consistent and meaningful engagement practices. The study also identified a number of potential enablers for creating systematic and consistent PE: the use of digital tools, cost-effective engagement methods, culturally sensitive communication approaches, partnerships with patient advocacy groups and the establishment of PE as a recognised scientific discipline. This research emphasised the need for robust methodologies and standardised PE practices to demonstrate return on engagement and its contribution to successful development of innovative medicines.

Research efforts within the Centre for Pharmaceutical Medicine Research, King’s College London, are advancing patient engagement in medicine development and communications through evidence generation. This article presents the ongoing work of two doctoral researchers within the department, whose joint efforts aim to contribute to the evidence base on the integration of meaningful and sustainable patient engagement and involvement across the medicine development life-cycle and within peer-reviewed publications. These works have so far included a systematic literature review as well as qualitative interview-based analyses of both the perceived value of patient engagement across stake- holders and the landscape of patient involvement practices within peer-reviewed publications. Together, these research themes share foundational values, activities, and aspirations that this article explores within a framework of patients communicating to industry, industry communicating to patients, and patients and industry communicating with each other.