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Defining the quality of data within rare disease registries: A systematic review - Volume 34, Issue

Rare diseases have a low prevalence within society, resulting in limited awareness and challenges with data availability for research. While rare disease registries offer valuable data, ensuring quality of the data is essential. This review explores…

The paradigm of real-word evidence in lifestyle medicine: Insights, considerations, and opportunities for medical writers - Volume 34, Issue

Non-communicable diseases are rising at an alarming rate across the globe, with many attributed to our sedentary habits, unhealthy diets, chronic stress, poor sleep, and social, and environmental factors. Lifestyle medicine is an evidence-based…

Effective authoring of clinical study reports: A companion guide - Volume 23, Issue

‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…

Quality of life measures – an overview - Volume 27, Issue

HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

Systematic hospital collection of patient-reported outcome data via patient apps - Volume 27, Issue

Medical writers are increasingly likely to come across patient apps in their work, and we describe here the background and use of two apps for assessing patient-reported outcome (PRO). Systematic collection of PRO data via patient apps has been…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations - Volume 25, Issue

The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…

Enhancing accessibility of study data: The development of a graphical abstract for lay summaries of clinical trial results - Volume 29, Issue

We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…

Lingua Franca and Beyond - Volume 24, Issue

Business models in the field of medical and regulatory writing – can you think of a more suitable topic for discussing: collaboration, team working, and sharing complementary skills across different native languages? In this issue of Medical…

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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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