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Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

Changing methods to assess targeted therapies in oncology - Volume 27, Issue

New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…

Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age - Volume 33, Issue

With scientific advances during the COVID- 19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase h…

Can readers spot the AI impostor in healthcare writing? - Volume 32, Issue

The use of artificial intelligence (AI) writing assistants in the healthcare industry is becoming increasingly prevalent. These tools can help medical writers to generate content more quickly and efficiently, but they also raise concerns about the…

Abstracts from the 57th EMWA Conference Poster Session - Volume 33, Issue

EMWA’s spring conference in Valencia featured 18 posters on a wide variety of topics of interest to medical writers. Clinical trial regulations, plain language summaries, graphical abstracts, and document quality control are just a few of the…

Advancing health equity through language access – a global imperative - Volume 33, Issue

In this article, the authors outline the universal right to health, healthcare, and language access in healthcare, with a focus on policies and practices in the European Union and the United States. The authors spotlight contrasting views on whether…

In the Bookstores - Volume 28, Issue

Yellowlees Douglas is a con sult - ant on writing and organisations and an associate professor in the Center for Management Com - munication at the University of Florida, USA. Maria B Grant is a professor of ophthalmology at the University of…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editor: Kimi Uegaki Breaking barriers in sustainable development in East Africa: How Lightup Impact is leveraging communications to shift the power to the right actors Authors: Nicole Bezuidenhout, Valeria Santoro, Jeniffer Muganda …

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editors: Louisa Ludwig-Begall, Sarah Kabani How close are we to sustainability? Author: Catarina Leitão I have always loved nature. When I was a kid, I preferred watching wildlife documentaries to cartoons. Those documentaries taught me…

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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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