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Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

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,…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

News from the EMA - Volume 30, Issue

Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

English Grammar and Style - Volume 21, Issue

Good Writing Practice As an editor, I have been battling against verbosity, redundant modifiers, and ‘buzz’ words for many years. New terms and turns of phrase or new meanings for words pop up all the time. Many of them have come with the…

PhD student: A medical writer in the making! - Volume 27, Issue

With the ever-increasing stock of PhD holders and the diminishing number of permanent academic positions, alternative careers are in demand. Before the impostor syndrome marches in, these graduates need to realise that there can be a bright future,…

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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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