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Many of the key decisions in our lives concern our health and well-being.These decisions are often made for us at the societal level, but as individuals we have increasing say in the management of our own healthcare and in societal decisions. Having…
How results are reported influences how they are interpreted. Although P values have been granted great importance, they have no clinical interpretation. Rather, they are a measure of chance as an explanation for the results. Their either or…
This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
Using an outline to organize your writing project can help keep you on a straight path and avoid wandering into wastelands of irrelevance. There are various formats – the classic hierarchal model, the IMRAD system used for research reports, the…
Meta-analysis is a statistical technique for summarising the results of multiple studies in a quantitative manner. It should not be confused with a systematic review, though in practice the two are often found together. The main pitfalls with…
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…
The process of developing a novel drug is time consuming and costly. To increase the chances of successfully completing a clinical trial leading to the approval of a new drug, the choice of appropriate preclinical models is of utmost importance.…
‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…
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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