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Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results - Volume 34, Issue

The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…

Translating “medicalese”: The case of informed consent forms - Volume 33, Issue

Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…

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…

In this issue of Medical Writing - Volume 23, Issue

Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

Medical Communication - Volume 22, Issue

Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…

The ABCs of paediatric plain language summaries - Volume 30, Issue

Plain language summaries need to be written at a proficiency level of 2 to 3, which roughly corresponds to a 6th grade to 8th grade reading level. Writing these for paediatric audiences brings even greater challenges. For communication to be…

Medical Communication - Volume 27, Issue

At the start of a medical writing career, the quality control (QC) step can fill writers with a sense of dread. Someone is holding a magnifying glass to your carefully crafted (and at this point deeply loved) document and is trying to pick holes in…

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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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