Adeline Rosenberg

Background: Patient authorship and involvement in peer-reviewed publications is an increasing and evolving practice across the pharmaceutical industry, however implementation remains inconsistent and there is a need for specific and comprehensive guidelines. Methods: This practice-informed systematic literature review and qualitative evidence synthesis searched the peer-reviewed and grey literature (1 Jan 2018–1 June 2025) for meta-research, thought leadership, or commentaries about patient involvement in publications. Qualitative extractions were split into three datasets of best practices, gaps, and recommendations. Best practice codes were then categorised and synthesised into evidence-based best practices using meta-aggregative pragmatic inquiry and mapped to the stages of the publication lifecycle. As secondary, a priori analyses, a subset of codes relating to conflicting topics from the codebook generated using the best practice dataset were then deductively applied to the gaps and recommendations datasets and analysed for interpretation and expansion of concepts using reflexive thematic analysis. Results: A total of 166 peer-reviewed literature and grey literature records were included in the reviewed, resulting in a synthesis of 66 best practices for patient involvement in peer-reviewed publications across and beyond the publication lifecycle. Two conflicting best practice topics required secondary analysis, namely the discourse on how patient authors should be identified and affiliated and if patient authors can be remunerated. Conclusions: Here we establish and propose an evidence-based framework of best practices for patient authorship and involvement in pharmaceutical industry peer-reviewed publications to improve consistency and standardisation. Further consensus is needed on topics of patient author affiliations and remuneration. Systematic review registration: PROSPERO. CRD420251030982.

Patient authorship, in particular the inclusion of patient representatives or patient partners as external authors on company-sponsored publications, is increasingly observed1,2. Patients in this c...

Background: Patient involvement within academic and for-profit medicines and medical technology research and development is happening across organisations and functions. Frameworks exist to conceptualise involvement activities along a spectrum based on patient contributions and their share of voice and decision-making. Examples range from Informing and Education of patients through to Co-design and Co-Production e.g., in research and development. Varying levels of patient expertise profiles also exist based on a spectrum of experience and expertise – from Patient by Experience through to Patient Key Opinion Leader (KOL) – though researchers often lack clarity on the most relevant skills and knowledge of patient partners suited to the task at hand. Here, we propose a conceptual matrix model combining these two concepts into a simple, pragmatic framework intended for patient involvement professionals in research and development, but with broader relevance for other contexts. Methods: As authors with a mix of academic, for-profit industry, and patient advocacy backgrounds, we utilised intellectual exchange and consensus formation in three workshops to develop the model. Results: We have developed a conceptual matrix model and applied illustrative case study examples from among our collective experiences and network to demonstrate the model in action. Trends in sample sizes, patient diversity, project longevity, and share of influence exist along the matrix axes. For example, greater numbers and diversity of patients are typically seen at the lower levels of involvement, where there is greater capacity for breadth of involvement. Conclusions: Our aim for this model is to support and encourage patient involvement professionals to better determine appropriate levels of involvement and patient expertise needed for their projects and activities, enabling them to facilitate more appropriate, fair, effective, and sustainable patient involvement.

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.

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.

To assess health inequalities research involving the pharmaceutical industry and to highlight key themes and potential research gaps. Briefly, a literature search of article titles on the Embase and MEDLINE databases was performed to identify relevant peer-reviewed literature published between 2000 and 2023. A review of gray literature sources and pharmaceutical company global websites was performed in parallel. Peer-reviewed literature and gray literature were excluded during pre-screening based on pre-defined eligibility criteria. Peer-reviewed publications that met the eligibility criteria underwent double-blind title and abstract screening to determine relevance to health inequalities research; gray literature was screened by one reviewer. All publications included after title and abstract screening underwent full-text review. The peer-reviewed literature search yielded 1,377 initial results, of which 18 publications were included for data extraction; the gray literature search yielded 10 articles. Peer-reviewed publications involving the pharmaceutical industry increased over the past 5 years. North America was included as the region of research focus or study population in 61.1% (11/18) of the peer-reviewed publications. Health inequalities across race/ethnicity (66.7% [12/18]), sex/gender (44.4% [8/18]) and socioeconomic status (27.8% [5/18]) featured in the identified publications. Across the medicines and vaccines development and launch process, 71.4% (5/7) of the publications focused on increasing clinical trial participant diversity. The pharmaceutical industry has contributed to the discussion on health inequalities, particularly over the past 5 years. However, industry can better take the wider determinants of health into consideration when designing strategies of evidence generation across the medicines development pathway.

Key points: Plain language summaries (PLS) are accessible, short, peer‐reviewed summaries of scholarly journal articles written in non‐technical language. The aim of PLS is to enable a broader audience of experts and non‐experts to understand the original article. Here, we outline the evidence base for the value and impact of PLS and how they can enable diversity, equity, inclusion and accessibility in scholarly publishing. PLS can diversify readership and authorship, address information inequity, include typically under‐represented stakeholders and provide an accessible route into scholarly literature.

Scientific publishing is evolving, and if the spike in interest about plain language summaries over the past several years is any sign of the appetite for adding open science principles to our publishing practices, then the future of accessible research is looking bright. What Are Plain Language Summaries? Plain language summaries (PLS) are typically short synopses of peer-reviewed journal publications that simplify the complex. PLS concisely summarize technical content in simple, jargon-free language for ease of reading and improved understanding. These summaries are intended for a broad and inclusive audience that encompasses anyone who may wish to engage with a piece of published research. This may include researchers from other specialties or of other native languages, science communicators, educators, policymakers, and the media, as well as the general public. This multistakeholder audience is essentially anyone seeking an accessible route to the scientific literature. In biomedical research, this list expands to include the likes of patients, patient advocates, caregivers, and healthcare professionals. As a practice that is still growing and maturing, standardization is limited, and PLS currently come in many different formats (including multimedia) depending on individual journal requirements and author preferences.1 The location in which PLS can be found also varies, with journals hosting these within the main manuscript PDF and web page, in supplementary materials, or on third-party websites such as figshare.com. Some authors and research sponsors are opting to host PLS themselves if journals do not offer sufficient options; the publisher Future Science Group is even offering standalone […]