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In a post-pandemic world, master protocol studies will be an integral part of the “new normal” for clinical research and play an important role in providing actionable data to support health policy and resource allocation. Medical writers and study…
Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…
The reach and impact of social media have made this communication channel the latest in a number of multidimensional communi - cation tools to be employed in health research. Social media has become a com - muni cation tool to reach various…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
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…
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…
The 2 year EMWA-AMWA CORE Reference project resulted in the publication of the open-access CORE Reference at http://www.core-reference.org on 03 May 2016. The full peer-reviewed publication supporting the launch of CORE Reference: Hamilton S,…
The official journal of the European Medical Writers Association (EMWA) has changed its name from The Write Stuff to Medical Writing, which is being published by Maney Publishing. This marks a leap forward for the journal, which is now in its 19th…
Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
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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