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Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…
The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…
Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…
This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…
The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…
The freelance medical writing landscape has evolved in recent years, with more market demand for competent medical writers who can work on a project basis. In January 2023, the European Medical Writers Association’s (EMWA) Freelance Business Group…
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…
Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the…
Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…
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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