Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Publications - Volume 33, Issue

Section Editor: Maddy Dyer Can patients and caregivers be authors of peer-reviewed publications? Authors: Phil Leventhal, Danielle Drachmann, Soren Skovlund Medical Writing. 2024;33(4):98–100. https://doi.org/10.56012/idde2040

Lingua Franca and Beyond - Volume 30, Issue

Our mentors It is my great pleasure to introduce this article written by Julia Bates from Australia, who in a very personal way describes her journey to becoming a very professional and experienced medical writer – a journey that often went across…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…

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…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

Medical Communications and Writing for Patients - Volume 33, Issue

Section Editor: Lisa Chamberlain James

Involving patients in company-sponsored medical publications: Learning from collaboration with a patient advocacy group to engage patient authors

Authors: Aki Yoshikawa, Atsuko Iwata, Miho Hatano, Yuko Koji…