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The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
The use of vaccines and immunotherapies in medicine dates back to the end of the 18th century and the work of Edward Jenner, the father of immunology. Jenner, building on the observations of John Fewster in 1768, showed that inoculation with the…
EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…
Comics aren’t just for kids. They’re a provo - cative, entertaining, and storytelling medium powerful enough to captivate people of all ages, all languages, and all cultures – no small feat in today’s era of instant gratification. To engage our…
In September 2021, the editors-in-chief of over 200 biomedical and scientific journals from all geographic regions issued a call for Emergency Action to Limit Global Temperature Increases, Restore Biodiversity, and Protect Health.1 This editorial…
Hundreds of statistical tests, procedures, and descriptive measures are used in clinical research. Risks, odds, and hazards are among the most common but not always the most understood. They are often used in all three types of observational studies…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
In this first issue of 2018, I’m delighted to introduce an excellent article from one of EMWA’s newest Workshop Leaders, John Dixon. Although John is new to teaching at EMWA, he’s extremely experienced in his field – or, more correctly, fields! John…
Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…
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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