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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…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
Until recently, statistics was a subject that I avoided at all costs. I found it difficult to understand and boring, and for years I swore that I would never learn about or be interested in statistics. (By the way, I also swore that I would never…
The financial relationships between the pharmaceutical and device industries and healthcare practitioners appear frequently in the spotlight because of their potential to create bias and influence prescribing choices. Public disclosure of these…
Drugs companies publish only a fraction of their results and keep much of the information to themselves. Drug companies are ‘debasing’ drug trials whose publication in journals can apparently confer scientific approval. Merck had fought for years to …
“For many people, the internet can feel like a lonely place. It can feel like… a big, endless, expansive void where you can constantly call out to it but no one’s ever listening. But… I found, in sharing my feelings with the void, event…
Dear colleagues Time really does fly when you're having fun: I'm writing my third message since becoming EMWA President in May! The 37th EMWA Conference in Barcelona was an exciting event in a great location. We welcomed 102 new members, and 240…
The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…
Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…
Medical translation training around Europe It’s been said a thousand times, yet, many are still not fully aware of the importance that translation has in our daily lives. Rather than merely supplanting one form of words with another, the translator…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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