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Protecting the rights of clinical trial patients through disclosure: The significance of plain language - Volume 27, Issue

Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technicalsubmission-level…

Regulatory Writing Briefing documents: A case apart - Volume 24, Issue

Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…

Developing a treatment for ovarian cancer - Volume 21, Issue

Ovarian cancer is a really nasty disease. Although, like most cancers, it is curable if caught early enough, in practice it is not usually diagnosed until it is too late for curative treatment. It initially responds well to treatment and patients…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

My First Medical Writing - Volume 33, Issue

Section Editor: Evguenia Alechine I’m glad to be sharing the work of a rising star in the medical writing and science communication world. On this occasion, I had the pleasure of working with Valentina Torres Monserrat, who has a degree in…

Penning hope: The impact of medical writing for rare conditions - Volume 34, Issue

In this article, I explain my route into the world of rare conditions, my experience of working as a clinician, and my passion for raising awareness to all involved. I achieve this by providing education to healthcare professionals, patients, and…

Regulatory Writing - Volume 21, Issue

The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…

Veterinary Medical Writing - Volume 28, Issue

With veterinary treatment options becoming more diverse and advancing rapidly, the demand for veterinary medical writers is growing. Currently we are a growing group of vets in EMWA and we look forward to welcoming more colleagues to our…

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…

Writing lay summaries: What medical writers need to know - Volume 27, Issue

Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…

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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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