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Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…
Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the…
Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…
In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
Scientific and medical publications are the pulse of the clinical world and play a key role in disseminating data to healthcare providers, scientists, and researchers. However, the process of publishing is hampered by the lack of harmonisation in…
Knowing that the main theme of this issue of Medical Writing is writing for the lay audience, I was thinking hard about what would be the most relevant topic to discuss in the Lingua Franca and Beyond section. My thoughts went to a topic that…
The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…
The increased prevalence of healthcare-related social media and other web-based communications has generated interest in tools that measure the attention and engagement of published content. In the context of medical research publications, the use…
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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