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History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

In the Bookstores - Volume 26, Issue

Publishing Your Medical Research (Second Edition)Daniel W. ByrneWolters Kluwer, 2017Daniel Byrne has taught courses on biostatistics and medical writing at Vanderbilt University since 1999. He wrote the first edition of Publishing Your Medical…

The evolution of biotechnology: From ancient civilisations to modern day - Volume 32, Issue

This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the…

EMWA News - Volume 25, Issue

EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…

Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO - Volume 25, Issue

The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Digital Communication - Volume 32, Issue

Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…

Guidelines for disclosing the results from observational trials - Volume 26, Issue

Observational trials are a relevant part of clinical research. Publishing their results can be challenging for scientists and writers. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement was the first…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

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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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