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The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

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…

Patient education accessibility - Volume 24, Issue

Patient education that overcomes literacy barriers supports quality care. This article provides an overview of health literacy, describes the concepts of readability and accessibility, and discusses how to empathise with the patient's experience and…

Get your (visual) act together: Optimising the design of labels and arrows in medical illustrations - Volume 29, Issue

There is an enhanced communicating power of text when associated with visuals. This is a compelling argument for furnishing medical writers with basic knowledge on how to adapt and create simple figures. This article discusses tips on adding labels…

Guidelines for disclosing the results from observational trials - Volume 26, Issue

Observational trials are a relevant part of clinical research. Publishing their results can be challenging for scientists and writers. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement was the first…

Adverse event reporting: A brief overview of MedDRA - Volume 23, Issue

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…

How to interpret and report the results from multivariable analyses - Volume 25, Issue

Multivariable analyses are some of the central statistical methods of clinical trials, and yet some medical writers may be unsure as to what they are and how best to interpret and report the results. In this article we provide an overview of…

Go certified – get ready for the BELS exam - Volume 27, Issue

If you are a manuscript editor, you can earn a certification through the Board of Editors in the Life Sciences (BELS), attesting your editorial proficiency. Such objective evidence is desirable for many writers and editors in the life sciences –…

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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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