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The COVID-19 pandemic has significantly impacted the whole world, and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine…
Health literacy is defined as “the knowledge, motivation, and competence to access, understand, appraise and apply information to make decisions in terms of healthcare, disease prevention, and health promotion” according to Quaglio et al.5 Poor…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Unsung heroes: The medical writer’s role in clinical trials The medical writer is heavily involved in clinical trials from A to Z and even beyond. Although we are not in the frontline, our role is nevertheless crucial as we develop most of the…
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…
Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…
The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…
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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