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Population diversity in clinical trials for rare diseases: A regulatory writer’s perspective - Volume 34, Issue

Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…

Medical writing in the Russian Federation: Promises and pitfalls - Volume 22, Issue

More and more clinical studies are taking place in Russia, making it an attractive market for medical writing. In 2011, the Ministry of Healthcare of the Russian Federation approved over 550 new clinical studies of all types, a 16% increase over the…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

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…

Narratives for a clinical study report: The evolution of automation and artificial intelligence - Volume 32, Issue

Automation and artificial intelligence (AI) are useful tools that are rapidly progressing in many fields within the clinical trial landscape, and their use in the production of narratives for clinical study reports is no exception. Technology and…

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…

Regulatory Writing: New developments in public disclosure of clinical trials - Volume 24, Issue

In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…

Visual aids in patient-focused drug development and routine clinical practice - Volume 34, Issue

Effective medical communication is critical for patient consent, adherence to treatment, and improved health outcomes. Visual aids, such as infographics, diagrams, and charts, have proven invaluable for enhancing comprehension, particularly of…

Patient education in clinical trials and throughout the product lifecycle - Volume 25, Issue

Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…

Medicinal products and medical devices in clinical trials conduct and disclosure - Volume 28, Issue

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…

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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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