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Navigating the complex landscape of clinical trial transparency: What medical writers need to know - Volume 33, Issue

Clinical trial transparency is beneficial for patients, researchers, and the general public. However, rapidly evolving regulatory requirements for transparency have increased the information that will be published. Medical writers can play a key…

Publications - Volume 33, Issue

ICMJE recommendations update: What’s new? Section Editor/Author: Maddy Dyer In January 2024, the International Committee of Medical Journal Editors (ICMJE) updated their “Recommendations for the Conduct, Reporting, Editing, and Publication of…

Announcing AERTeM, the Spanish Association of Medical Writers - Volume 22, Issue

The Spanish Association of Medical Writers – in Spanish, the Asociación Española de Redactores de Textos Médicos (AERTeM) – is a young association focused on the specific needs of Spanish writers. Local organisations such as AERTeM can augment the…

President's Message - Volume 24, Issue

Welcome to the first issue of medical writing in 2015 on plain language, which means that this message had better be simple and easy to read. I am a huge advocate of plain writing and, as a Publication Manager, spend much of my time working with…

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…

Medical Devices - Volume 30, Issue

Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…

Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

Rush to publication – What do we have to lose? - Volume 29, Issue

Just as the research and development of new drugs requires careful, often painstaking, adherence to empirical processes, the peer-review process and, indeed, the manuscript preparation process, are likewise laborious and time-consuming. The benefits…

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…

Covering a medical advisory board meeting and creating the report or publication: The role of the professional medical writer - Volume 25, Issue

Medical advisory board meetings are anintegral part of the healthcare and, inparticular, the pharmaceutical landscape.These meetings serve to identify knowledgegaps in a specific therapeutic area and tosuggest measures that could be implementedand…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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