This week, the UK government has launched an inquiry into research reproducibility and integrity, while the FDA has issued its second warning for failure to report a clinical trial outcome. Meanwhile, we hear from the author of an open letter calling for harmonized access to clinical study reports and learn about the issue with English language dominance in research publishing. Finally, we look at standalone plain language summaries of publications and discuss the evolving relationship between universities and publishers.
Parliamentary committee launches inquiry into research reproducibility via UK Parliament | 2-minute read
The UK government’s Science and Technology Committee has launched an inquiry into the reproducibility and integrity of research. Ever since the publication of a highly cited 2005 study in PLOS Medicine titled Why most published research findings are false, there have been concerns that science is experiencing a ‘reproducibility crisis’. In this call for evidence, the parliamentary committee is seeking input on the breadth of the reproducibility crisis, its causes, where accountability lies, and solutions to the issue.
FDA issues second non-compliance notice via TranspariMED | 7-minute read
In 2007, the Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated that sponsors must report clinical trial outcomes on ClinicalTrials.gov within 12 months of study completion. On 26 July, the FDA issued its second ever non-compliance warning since the mandate started, with the first such notice being issued earlier this year. The FDA has been frequently criticized for not routinely enforcing this mandate and for the negative effect its lack of enforcement may have on public trust in science. The University of Oxford’s FDAAA TrialsTracker estimates that at least 2811 clinical trials have unreported outcomes.
Open letter to increase clinical study report transparency via the BMJ Opinion | 4-minute read
The right to obtain clinical study reports (CSRs) – which provide extensive information about the methods and results of a clinical trial – varies across national drug regulators in Europe. Although the European Medicines Agency (EMA) mandates transparency of CSRs, national drug regulators are not currently required to follow these policies. Instead, they may follow the country’s local legislation, which may conflict with the EMA policies. In May 2021, an open letter was written to the Heads of Medicines Agencies urging harmonization of access to CSRs in Europe. In this article, Kim Boesen, co-author of the open letter, discusses the aims of the letter and the importance of free access to CSRs.
Open science could rebalance English language dominance via EL PAÍS | 5-minute read
Last year, 95% of all scientific journal articles across the globe were published in English. As a result, most research in non-English-speaking countries was inaccessible to large proportions of the populations of those countries. This article looks at Spanish- and Portuguese-speaking countries in particular, where 84% of researchers publish their work in English. Behind this English language hegemony are reasons of status, citation impact and a desire for articles to be understood by researchers in the USA. A proposed solution is to increase open-access publishing and implement automatic translation of articles into local languages.
Focus on plain language summaries of publications via ALPSP | 4-minute read
Future Science Group (FSG)’s Plain Language Summaries of Publications (PLSPs) have been shortlisted for the Association of Learned and Professional Society Publishers (ALPSP) Awards for Innovation in Publishing 2021. PLSPs are standalone lay summaries of articles published in FSG journals. They are usually written by the authors of the original articles and are both citable and peer reviewed. As finalists for the ALPSP awards, FSG discusses how PLSPs are discoverable by non-specialist audiences such as patient groups and how they integrate well with social media. The awards session will take place on 15 September 2021.
Universities and publishers need to reassess relationship via Samuel Moore Open Notebook | 7-minute read
The success of open access models largely hinges on universities and publishers negotiating agreements that suit both parties. In this piece, scholarly communications specialist Samuel Moore explains how the current drive towards open access has left publishers scrambling to protect profit margins and defend their role in scholarly communications. Meanwhile, universities may need to reassess the outsourcing of both knowledge dissemination and researcher evaluation to publishers. Additionally, the Rights Retention Strategy is causing further friction between universities and publishers because it allows institutions to circumvent the publisher’s right to ownership of an author’s work.
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