Weekly digest: accessible language, clinical trial transparency, and publication bias

Mark Elms

This week, we read another article from the December 2022 issue of Medical Writing, which discusses the differing accessible language document terminology used in medical communications. We hear about the the EMA’s revival of its clinical study reports publishing policy, and we look at clinical trial transparency best practice and obstacles. We read about publication bias in registered Australian and New Zealand trials, open access news from Texas and India, and best practice for open science events. Finally, we highlight a three-part webinar on data science, and we watch a video predicting what 2023 will bring for the pharma industry.

To read:

The differing terminologies of accessible language documents via Medical Writing | 15-minute read

There is often confusion between the different types of accessible language documents and their purposes and audiences. The three main types are regulatory lay summaries, publication-associated plain language summaries, and plain language summaries of publications, and the confusion often arises due to the similarity of terminology. This article, written by Sarah Griffiths, Ama Appiah and Adeline Rosenberg from Oxford PharmaGenesis alongside John Gonzalez and Slávka Barónikova from Galapagos, looks at the different names used for accessible language documents across 58 pharma companies. The authors also discuss the different literacy levels used in these documents and give recommendations for best practice when writing.

EMA to enhance clinical trial transparency via TranspariMED | 3-minute read

The European Medicines Agency (EMA) is set to revive its policy of making clinical study reports (CSRs) freely available to researchers and the public. In 2016, the EMA became the first medicine regulator worldwide to make CSRs publicly available, but the policy was dropped in 2018 owing to staff shortages and the subsequent COVID-19 pandemic. However, the EMA announced at their December 2022 management board meeting that the CSR publication policy is planned to restart in 2023.

What are the barriers to clinical trial transparency? via The Publication Plan | 4-minute read

Transparency in clinical trials often hits against obstacles such as copyright licensing, patient confidentiality and data management. This summary of an article published in Science and Public Policy highlights four key components that clinical trial teams need to consider in order to improve transparency and avoid these obstacles. These components are trial registration, data documentation, data sharing and publishing trial outcomes. The summary also discusses some of the recent mandates for clinical trial transparency and the latest Good Publication Practice Guidelines, as well as presenting suggestions on how to increase transparency.

Publication bias in trials registered in the ANZCTR via PLOS ONE | 25-minute read

Publication bias can result from authors tending to publish positive and significant results, with studies and trials giving negative results often remaining unpublished. This study, published in PLOS ONE, looked at the publication rates and the time to publication of 1970 trial registrations in the Australian New Zealand Clinical Trials Registry (ANZCTR). They found that 27% of trials registered in 2007, 2009 and 2011 remained unpublished 10 to 14 years after first participant enrolment.

What’s the Big Deal: news from Texas and India via The Scholarly Kitchen | 5-minute read

Recent years have shown progress towards universal open access through policies such as federal open access mandates, transformative agreements and funders requiring open access publishing. But, this article argues, some recent developments are swimming against the open access tide. For instance, the article discusses an agreement between Elsevier and 44 Texan universities (the Texas Library Coalition for United Action), as well as India’s national ‘One Nation One Subscription’ program, describing them as reimaginations of the much-maligned ‘Big Deal’ that pushes against open access.

Best practice for open science events via PsyArXiv | 12-minute read

This preprint, hosted on PsyArXiv, discusses best practice policies for planning, running and expanding open science events. These open science events include talks, podcasts, summer schools, workshops, panels and series, with the authors evaluating each event based on their accessibility, feasibility, scalability, specificity and needed expertise. The authors base their recommendations on the central aim of teaching participants a certain open science skill or competency while ensuring that the events are accessible and motivational for all involved.

To engage with:

A three-part webinar series on data science in biomedical research via Friends of the National Library of Medicine

The Friends of the National Library of Medicine are hosting a three-part webinar series titled Advanced Methods of Data Science in Biomedical Research. Targeted towards biomedical researchers, librarians, health informaticians and health professionals, the series aims to discuss the latest developments in scientific data management requirements, scientific data repositories, and scientific publication practices. The first webinar will be taking place on 18 January 2023, with subsequent webinars on 8 February and 15 February. You can sign up for the webinars here (there is a fee for registration).

To watch:

2023 predictions for the pharma world via Impatient Health | 1-hour watch

Watch this crystal ball gazing session with Paul Simms (CEO of Impatient and former Chairman and CEO of Reuters Events Pharma) where he predicts the forces and trends that will shape the pharma world in 2023. Paul discusses everything from ChatGPT to the rise of synthetic data to Elon Musk potentially wading into pharma. You can see whether you agree with him or not here!

Have you read the December 2022 issue of Medical Writing about Open Science and Open Pharma? Read the full issue here!