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The need for community: The importance of networking as a freelance medical writer - Volume 32, Issue

Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…

Introduction - Volume 28, Issue

When I first stepped into the biosimilar world as part of my medical writing career development, I was both excited and surprised. I was entering this fascinating setting with an originator mindset, as many of us do, and discovered that there are…

Reporting health economic evaluations: CHEERS and beyond - Volume 30, Issue

Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…

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)…

Update of the Consolidated Health Economic Evaluation Reporting Standards: CHEERS 2022 - Volume 31, Issue

If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…

The launch publication for Clarity and Openness in Reporting: E3-based (CORE) Reference

The 2 year EMWA-AMWA CORE Reference project resulted in the publication of the open-access CORE Reference at http://www.core-reference.org on 03 May 2016. The full peer-reviewed publication supporting the launch of CORE Reference: Hamilton S,…

Reporting of preclinical research: What do we get told – when and how? - Volume 26, Issue

At present, there are no specific requirements for the reporting of preclinical research, and many studies, particularly those with negative results, never get published. Despite the huge advances in communication opportunities, things have not…

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…

News from the EMA - Volume 26, Issue

April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…

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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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