Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance - Volume 24, Issue

To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…

AI-based plagiarism detectors: Plagiarism fighters or makers? - Volume 32, Issue

Plagiarism damages the biomedical academic publication domain. Artificial intelligence (AI) is a rising hope in academic plagiarism hunting. However, new AI-based tools are available online to assist with plagiarising! This article presents…

Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

In the Bookstores - Volume 22, Issue

While other guides focus on how to write scientific papers, What Editors Want advises on preparing them for publication. Its authors, Philippa Benson and Susan Silver, identify their target readers as writers, senior researchers, and teachers of…

In the Bookstores - Volume 23, Issue

To satisfy the inquisitive mind, Oxford University Press has since the year 2000 published books offering ‘A Very Short Introduction’ to a whole range of subjects. For example, 2013 saw the publication of introductory guides to, among other topics,…

Out on Our Own - Volume 29, Issue

I began freelance medical writing in 2017 after 5 years of medical writing at several agencies. During this time, I realised that I wanted to be a freelancer when I was constantly needing and searching for freelance support during what seemed like…

A primer on anonymisation - Volume 28, Issue

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…

Journal Watch - Volume 22, Issue

The August 2013 issue of European Science Editing (ESE), the journal of the European Association of Science Editors, included a couple of articles relating to the San Francisco Declaration on Research Assessment, on which I comment elsewhere in this…

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…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…