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…

Population diversity in clinical trials for rare diseases: A regulatory writer’s perspective - Volume 34, Issue

Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…

From the Editor - On social media: Once a passive observer – now an active user - Volume 30, Issue

It is with great pleasure that I write my first editorial for this amazing issue on social media. The idea of this issue came to me in 2019, inspired by two special colleagues.

I had social media accounts even before I became a medical writer. I rec…

Subcontracting: Not for the faint of heart - Volume 28, Issue

Subcontracting can be the answer to a successful freelancer’s prayers, or the opportunity to work harder than you have ever worked before for less money than you made when you were a struggling newbie. The potential advantages of subcontracting are…

English Grammar and Style - Volume 21, Issue

Good Writing Practice As an editor, I have been battling against verbosity, redundant modifiers, and ‘buzz’ words for many years. New terms and turns of phrase or new meanings for words pop up all the time. Many of them have come with the…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

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…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Traversing the social media landscape: Digital health communications in 2024 Author: Shannen Young Amidst a post-pandemic landscape marked by dis- and misinformation, new technologies, and platform shifts,…

Publisher perspectives on plain language summaries of scientific publications: An Open Pharma survey - Volume 33, Issue

Plain language summaries (PLS) of scientific publications can help to make scientific literature more understandable. In healthcare, PLS can contribute to informed decision- making by healthcare professionals, patients, and their caregivers. In late …