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The regulatory-HTA decision-making interface: What the medical writer should know - Volume 30, Issue

For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

Statistical analyses and methods in the published literature: The SAMPL guidelines - Volume 25, Issue

Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…

ICMJE to mandate data sharing statements - Volume 26, Issue

Those of us who attended the 2017 spring conference in Birmingham were treated to an excellent symposium on transparency in clinical trials, where EU Policy 00701 on disclosure of clinical data was a key focus. A month later, theICMJE (International…

EMWA News - Volume 25, Issue

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…

Odd cases and risky cohorts: Measures of risk and association in observational studies - Volume 26, Issue

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…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

In the Bookstores - Volume 22, Issue

Bad Pharma is the latest book by the well-known anti-quackery campaigner Ben Goldacre, and attempts to explain to us that medicine is broken. Despite the title, he criticises not only the pharmaceutical industry, but also regulators, doctors,…

Medical Journalism - Volume 22, Issue

Medical journalism - a dream job? My name is Erich Lederer. I am a medical journalist. Is it the kind of work I always wanted to do? No, definitely not. I actually never dreamt of juggling with words and sentences and in school I always had very…

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Scope

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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