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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…
‘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…
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…
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…
There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain…
Data are being transmitted and stored on cloud-based networks, including clinical, research, and publishing data. These cloudbased systems often lack comprehensiveness, accessibility, interoperability, confidentiality,accountability, and…
A personal view incorporating the insights of a UK-based book group Henrietta Lacks was a 31-year-old African American who died in 1951 from cervical cancer. Her biopsied cancer cells were taken without her permission, propagated seemingly forever…
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…
As medical writing (MW) is a growing profession in India, we assessed the awareness among professional medical writers (PMWs) about their job and career prospects. We conducted an anonymous survey among PMWs (N=192) working in a global…
It is my real pleasure to welcome you to the second issue of Lingua Franca and Beyond, a regular feature of Medical Writing for non-native English speaking medical writers. As soon as I'd written those words, I realised that this section should not…
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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