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The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
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…
Journal Policies Editorial policies and peer review process All feature articles submitted to Medical Writing are reviewed by a member of the Editorial Board. All Editorial Board members are experts in the field of medical writing and members…
Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…
The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the…
Dear EMWA Members, As we came together in the historic city of The Hague in November 2015 for another successful and enjoyable conference, we were particularly delighted to welcome our Benelux members who turned out in force. The usual EMWA…
Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
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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