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The clinical development plan - Volume 31, Issue

The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…

Speaking your patients’ language – Is it really worth it? The impact of translation on multilingual patient education materials - Volume 33, Issue

This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

In the Bookstores - Volume 21, Issue

A personal view incorporating the insights of a UK-based book group Henrietta Lacks was a 31-year-old African American who died in 1951 from cervical cancer. Her biopsied cancer cells were taken without her permission, propagated seemingly forever…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

Five “translation” strategies to adapt technical content for lay audiences - Volume 33, Issue

Writing for lay audiences requires language that is understandable by readers without expertise in the subject matter at hand. This means carefully selecting, organising, wording, and supporting content, focusing on conveying relevant points in a…

How to combat medical misinformation with a sound content strategy - Volume 28, Issue

In our post-truth era of media and communications, implementing a sound content strategy can help your message reach the right individuals. It is time for experts and healthcare companies to lead the change as ethical and credible sources of…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

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…

AI-based plagiarism detectors: Plagiarism fighters or makers? - Volume 32, Issue

Plagiarism damages the biomedical academic publication domain. Artificial intelligence (AI) is a rising hope in academic plagiarism hunting. However, new AI-based tools are available online to assist with plagiarising! This article presents…

Regulatory Matters - Volume 30, Issue

The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…

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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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