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Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results - Volume 34, Issue

The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…

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…

Value of medical writing: The regulator's perspective - Volume 31, Issue

In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

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 journalism: Another way to write about science - Volume 24, Issue

True journalism differs from public relations and uncritically reproducing press releases. It involves doing background research into the context surrounding the finding being reported, seeking comments from independent experts, and highlighting the…

Speaking your patients’ language – Is it really worth it? The impact of translation on multilingual patient education materials - Volume 33, Issue

This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Quality assurance in medical translation - Volume 33, Issue

Quality assurance (QA) is an important part of the translation process; its ultimate aim is to ensure that a high-quality translation is produced. Traditionally, QA was very much a task undertaken by humans, but recent years have seen the advent of…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

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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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