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Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
This article examines the clarity of several health information leaflets issued to the public in Europe. It finds that some of the language is quirky, ambiguous, and confusing. In one leaflet, the size of type is too small for easy reading, even by…
Many people do not take their medicines as prescribed, and medicines can cause harm if not used appropriately. In addition, in most health systems there is increasing discussion about involving patients in decisions about their health – including…
Increasing amounts of information are being made available to patients – but how do we know if we are getting it right and meeting people's needs? In this article, we describe how we have employed user testing to test and improve not just…
I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
Having left the office for 5 days to go to the EMWA Spring Conference, I returned to the obligatory email avalanche. While it was mostly junk (and unfortunately still no ‘congratulations on winning the lottery’ message…), there were some messages…
Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that is…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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