Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications.

Plain language summaries of peer-reviewed medical journal publications are a means of sharing research with a broad range of audiences and may improve the transparency, accountability, accessibility, discoverability, and inclusivity of medical research. There is currently an ongoing, industry-wide effort to establish consensus on plain language summaries, and initiatives are already in place that provide detailed guidance on plain language best practice, co-creation methods, patient-focused content, graphic and digital considerations, and publisher-specific guidelines. However, there remains a need for a foundational set of recommendations that complement existing initiatives to outline the minimum steps needed to develop discoverable, plain language summaries that are trustworthy, credible, and of high quality. Here, we present the Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications. These recommendations were initially developed by the Open Pharma Accessibility workstream and were extensively reviewed and refined during an expert roundtable and a focused, public consultation. Open Pharma is a multi-sponsor collaboration of pharmaceutical companies, non-pharmaceutical funders, publishers, patients, academics, regulators, editors, and societies seeking to identify and drive positive changes in the publishing of pharmaceutical company-funded research. We recommend that plain language summaries should be in the style of an abstract, free of technical jargon, unbiased, non-promotional, peer reviewed, and easily accessed. Plain language summaries should also meet the technical requirements to be indexed in directories such as PubMed. Ultimately, these recommendations are intended to be a concise outline of a minimum standard that provides top-line guidance on plain language summaries for authors, medical writers, publishers, and research funders.

PLAIN LANGUAGE SUMMARYArticles published in peer-reviewed medical journals are written using technical language. Plain language summaries are short summaries of these articles, written in everyday language that is easy to understand by anyone interested in medical research. This can include patients, patient advocates, caregivers, healthcare professionals, and policymakers. Sharing research through plain language summaries makes medical information more accessible and inclusive. However, few medical research articles include plain language summaries. The pharmaceutical industry has an opportunity to improve everyone's understanding of medical research by regularly developing plain language summaries of their articles. Plain language summaries can come in many different formats such as infographics and videos. However, text-only summaries are the easiest to find on internet search engines and research websites such as PubMed. Currently, there is limited guidance available to help researchers and medical journal publishers develop plain language summaries for their articles. In this article, 'Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications', we suggest a set of simple rules to help authors make and share text-only plain language summaries that we believe are possible for all articles reporting medical research. Once these have been met, we encourage researchers to consider making and sharing infographics and video summaries as well, to help people to understand their research even more.

Open access policies of leading medical journals: a cross-sectional study.

OBJECTIVES: Academical and not-for-profit research funders are increasingly requiring that the research they fund must be published open access, with some insisting on publishing with a Creative Commons Attribution (CC BY) licence to allow the broadest possible use. We aimed to clarify the open access variants provided by leading medical journals and record the availability of the CC BY licence for commercially funded research. METHODS: We identified medical journals with a 2015 impact factor of ≥15.0 on 24 May 2017, then excluded from the analysis journals that only publish review articles. Between 29 June 2017 and 26 July 2017, we collected information about each journal's open access policies from their websites and/or by email contact. We contacted the journals by email again between 6 December 2017 and 2 January 2018 to confirm our findings. RESULTS: Thirty-five medical journals publishing original research from 13 publishers were included in the analysis. All 35 journals offered some form of open access allowing articles to be free-to-read, either immediately on publication or after a delay of up to 12 months. Of these journals, 21 (60%) provided immediate open access with a CC BY licence under certain circumstances (eg, to specific research funders). Of these 21, 20 only offered a CC BY licence to authors funded by non-commercial organisations and one offered this option to any funder who required it. CONCLUSIONS: Most leading medical journals do not offer to authors reporting commercially funded research an open access licence that allows unrestricted sharing and adaptation of the published material. The journals' policies are therefore not aligned with open access declarations and guidelines. Commercial research funders lag behind academical funders in the development of mandatory open access policies, and it is time for them to work with publishers to advance the dissemination of the research they fund.

Real world evidence (RWE) - a disruptive innovation or the quiet evolution of medical evidence generation?

Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.