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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…

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,…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

Unlocking success as a book author: Navigating the essential social skills of writing gained through my PhD journey - Volume 33, Issue

This article explores the journey of transitioning from PhD to a book author, emphasising the importance of soft skills cultivated during academic pursuits. Drawing from personal experience, the author underscores the parallels between academia and a…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…

Advance your medical writing career with essential soft skills - Volume 33, Issue

Medical writing demands a comprehensive set of technical skills, from mastering regulatory and ethical guidelines to honing exceptional writing abilities. The foundation of superior medical writing is built on the hard skills acquired through educati…

Moving into medical writing from academia: A soft skills perspective - Volume 33, Issue

As I made the transition into medical writing and started learning the ropes, I realised first-hand that in addition to writing skills, soft skills are indispensable in becoming an effective medical writer. Not only are they vital in helping you…

The worldwide landscape of freelance medical writing: Exploring challenges and opportunities - Volume 33, Issue

The COVID-19 pandemic has had a significant impact on the pharmaceutical, biotechnology, and life sciences industries, ultimately affecting associated professionals such as freelance medical writers. Throughout this global event and its aftermath,…

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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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