Preventing biomedical research waste - Volume 31, Issue

An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…

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…

The role of translators: Adaptation of mental health tests beyond clinical research - Volume 33, Issue

This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…

Social media and the rise of predatory journals: A case report - Volume 30, Issue

This is a report of our experience with a predatory journal that invited us to join them after having seen our winning essays on how to identify predatory journals. We applied the system we recommended therein to investigate the true nature of the…

Narratives for a clinical study report: The evolution of automation and artificial intelligence - Volume 32, Issue

Automation and artificial intelligence (AI) are useful tools that are rapidly progressing in many fields within the clinical trial landscape, and their use in the production of narratives for clinical study reports is no exception. Technology and…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

The evolution of biotechnology: From ancient civilisations to modern day - Volume 32, Issue

This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the…

EU software regulations: The new normal or innovation stagnation? - Volume 29, Issue

Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Living medicine: The story of CAR T cell therapy - Volume 32, Issue

The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the…