Wait! What? There’s stuff missing from the scholarly record? - Volume 31, Issue

The scholarly record is an ever-evolving network – or graph – of truth assertions on which each discipline bases its discussions, and against which each discipline measures its progress. But what if the scholarly record is missing a significant…

Medical Devices - Volume 30, Issue

Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

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…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

Participant information – an ethics committee view - Volume 29, Issue

The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…

Someone in your corner: Musings of a mentor and mentee - Volume 30, Issue

What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…

Social Media - Volume 30, Issue

Social media

“For many people, the internet can feel like a lonely place. It can feel like… a big, endless, expansive void where you can constantly call out to it but no one’s ever listening. But… I found, in sharing my feelings with the void, event…