Patient involvement in publications: qualitative mapping of the current landscape within the pharmaceutical industry.

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.