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Writing for lay audiences, especially lay summaries, is needed to increase health and science literacy, but this kind of writing can be difficult for scientists. The article describes why it can be so difficult and gives some advice on how…
There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…
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…
Writing for lay audiences is recognised as a difficult task for medical writers, whose specialised knowledge can often hinder effective lay communication. This task is even more challenging when preparing clinical trial information for a…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…
Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
Writing for lay audiences requires language that is understandable by readers without expertise in the subject matter at hand. This means carefully selecting, organising, wording, and supporting content, focusing on conveying relevant points in a…
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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