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Patient reported outcomes - Volume 27, Issue

You are very welcome to this special edition of Medical Writing where the focus is on patient-reported outcomes (PROs). This is my second time to act as a guest editor. Once again, in the process of putting the issue together, I was highly impressed…

Exploring veterinary science, a little-known translation specialisation - Volume 23, Issue

Although closely linked to human health, veterinary science remains a relatively unexplored field for medical translators. The key to the specialisation may lie in the translators' ability to answer several key questions: • Who is the…

Finding the action in your writing: Avoiding nominalisation - Volume 26, Issue

Dense, hard-to-follow writing obfuscates complex subject matter, but writers can improve their ability to communicate complex topics with clear writing that is easily understood on a first read. Science and medical writing often contain grammatical…

The Webscout - Volume 21, Issue

Writing matters Writing matters – anything that matters in writing, or any writing that matters? I tend to interpret it the second way, but I asked Google what it thinks. It responded with some nice-to-read, worth-reading, and helpful sites. I…

ICMJE to mandate data sharing statements - Volume 26, Issue

Those of us who attended the 2017 spring conference in Birmingham were treated to an excellent symposium on transparency in clinical trials, where EU Policy 00701 on disclosure of clinical data was a key focus. A month later, theICMJE (International…

The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

MyData: Applying human-centric principles to health data - Volume 29, Issue

Modern data legislation increasingly empowers citizens, and therefore patients, with rights to access and control their health data. The mechanisms needed to exercise modern data rights are currently underdeveloped and underserving individuals and…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Regulatory Writing - Volume 21, Issue

The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…

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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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