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Patient-centred medicine has come out of the increasing importance of patients’ voices in disease management. As part of this, health related quality of life (HR-QoL) has become an important part of assessing treatment outcome and the quality of…
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…
An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…
Continuing medical education (CME) in Germany, as in other countries, is an estab - lished instrument for the delivery of ongoing training in medicine. Since September 2004, Deutsches Ärzteblatt has published 155 CME papers, and, as of the 12th of…
Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…
Before I write about my way from vet to journalist, I would like to make clear that neither my love for animals nor my admiration for James Herriot was the reason why I became a vet. When I was a kid, I dreamt, like many little girls, of being a vet…
Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…
In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…
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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AI/Automation
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EMWA News
Gained in Translation
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My First Medical Writing
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
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Chris Monk