No abstract

Plain language summaries of peer-reviewed publications are intended for everyone engaging with medical research, such as patients, patient advocates, caregivers, healthcare professionals, and policymakers. These summaries encourage discussions around medical research and aid fully informed and shared decision-making. The broad range of stakeholders involved in pharmaceutical research now puts the pharmaceutical industry in a unique position to make the medical publishing model more open. We believe that the next step of openness is to create a more accessible and inclusive environment through the routine development of plain language summaries of peer-reviewed medical journal publications.There are many formats of plain language summaries, but plain text is the most discoverable through indexing in directories such as PubMed. Standardizing the minimum steps for the development and sharing of index-friendly plain language summaries can help promote the quality and credibility of these lay communications. The aim of a minimum standard is to build a universal foundation that encourages the accessibility, discoverability, and inclusivity of plain language summaries. This standard can then serve as a basis for summaries written for a more specific target audience or that include graphically and digitally enhanced formats that increase understanding and engagement, which we strongly encourage.

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain language summaries of publications (PLSPs). Although these document types have different purposes and audiences, they are often confused because of the similar names. Here, we outline the main differences between the three document types and present the different names used to refer to lay summaries across 58 pharmaceutical companies, totalling 22 names. We also show examples of the different literacy levels used in lay summaries and publication-associated PLS. Medical publications professionals need to be aware of the differences between these accessible language document types and the importance of being precise when discussing these. Standardisation of terminology could potentially help to avoid confusion.

Clinical trial sponsors have ethical obligations to register protocols, report study results and comply with applicable legal requirements. To evaluate public commitments to trial disclosure and rates of disclosure by members and non-members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Websites of the top 50 biopharmaceutical companies by 2015 sales were searched for statements relating to trial data disclosure. Disclosure of trial results completed by biopharmaceutical industry and non-industry sponsors of at least 30 trials (2006–2015) was assessed using TrialsTracker. Among the top 50 companies, 30 were EFPIA/PhRMA members and 20 were non-members, of which 26 and none, respectively, had a statement on their website committing to the disclosure of trials data. Of 29 377 trials in TrialsTracker, 9511 were industry sponsored (69 companies) and 19 866 were non-industry sponsored (254 institutions). The overall mean disclosure rate was 55%, with higher rates for industry (74%) than for non-industry sponsors (46%). Of the 30 companies within the top 50 with data in TrialsTracker, the mean disclosure rate was 76% (77% for EFPIA/PhRMA members [n=25] vs 67% for non-members [n=5]). Most of the top 50 biopharmaceutical companies have publicly committed to the disclosure of trial data. Industry sponsors have responded to the ethical and legal demands of trial disclosure by disclosing three quarters of their trials compared with less than half for non-industry sponsors. Further improvements in clinical trial disclosure are needed.

Word count: 270/275 (incl. title and headings; excl. authors, affiliations and references; tables permitted and count for 100 words)