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Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…
Retracted publications, the issue of poor results reporting, and the increasing value of online teaching methods. Fang et al.1 think that it is important to evaluate scientific publications that have been retracted because they feel studying…
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…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
ICMJE recommendations update: What’s new? Section Editor/Author: Maddy Dyer In January 2024, the International Committee of Medical Journal Editors (ICMJE) updated their “Recommendations for the Conduct, Reporting, Editing, and Publication of…
Help, I can't shorten my abstract! Oh yes you can! (Part 1 of 2) Abstracts are perhaps the most important part of a manuscript because they are often the only part that is read and used as an information source. They are also used by readers…
Help, I can't shorten my abstract! Oh, yes you can (Part 2 of 2) Abstracts may be the most important part of a manuscript because they are often the only part that is read and used as an information source, and because they are also used by readers…
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…
Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…
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…
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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