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Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

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…

Getting Your Foot in the Door - Volume 28, Issue

The Vienna Conference is done and dusted. But the aftermath is so rewarding, as my knowledge has broadened and my network has widened. It was a joy to meet old colleagues but also get to know many people who are new to medical writing. In this…

Sluggish downloads, lagging video calls: Tips for the remote worker to tame technology - Volume 31, Issue

What are the various broadband options to consider when working from home and how can you ensure you’re getting the best from yours? Broadband failures can mean a headache for your clients and you risk looking unprofessional, so having a backup…

Leading a team virtually: A manager’s perspective - Volume 31, Issue

Remote working is the new normal since the COVID-19 pandemic, so learning to lead a virtual team successfully is now an essential core competency for organisational leaders. The transition from co-located teams to virtual teams has benefitted…

Pharmacovigilance - Volume 32, Issue

Ecopharmacovigilance: A review of cause, impact, and remedies The Pharmacoviligance section in this issue opens the door to a very interesting topic: ecopharmacovigilance. This article is the result of a collaboration among volunteers of EMWA’s…

Bringing decentralised clinical trial protocols to life - Volume 32, Issue

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…

Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD - Volume 32, Issue

Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…

Harmonising linguistic validation with AI: Precision, efficiency, and the human touch in patient-reported outcome translation - Volume 33, Issue

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…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

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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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