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Authors and Authorship - Volume 25, Issue

Authorship of medical journal articles has been and continues to bea complicated subject. The unethical practices of guest, honorary, andghost authorship and incomplete or biased disclosure of clinical trialdata have led to guidelines meant to…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

Mind the gap – towards complete and transparent reporting of animal research - Volume 26, Issue

Several initiatives have been taken to standardise the reporting of animal studies in peer-reviewed scientific journals, such as the ARRIVE (Animal Research: Reporting of In Vivo Experiments) and GSPC (Gold Standard Publication Checklist)…

Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer - Volume 25, Issue

Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…

Writing narrative style literature reviews - Volume 24, Issue

Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…

In The Bookstores - Volume 25, Issue

Guidelines for Reporting Health Research: A User’s Manual By David Moher (Editor), Douglas Altman (Editor), Kenneth Schulz (Editor), Iveta Simera (Editor), Elizabeth Wager (Editor) Wiley Blackwell, 2014. ISBN: 978-0-470-67044-6 (paperback) 32.99…

An introduction to little-known aspects of nonclinical regulatory writing - Volume 26, Issue

Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…

Biosimilar development – an overview - Volume 28, Issue

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

EMWA's position on ghostwriting - Volume 22, Issue

The European Medical Writers Association would like to make it clear that, contrary to what you may have read in a recently published popular science book, it is not a ‘ghostwriters' association’. EMWA is an association for professional medical…

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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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