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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…

Master protocol studies: Embracing the “new normal” - Volume 30, Issue

In a post-pandemic world, master protocol studies will be an integral part of the “new normal” for clinical research and play an important role in providing actionable data to support health policy and resource allocation. Medical writers and study…

Authors and Authorship - Volume 25, Issue

Authorship of medical journal articles has been and continues to bea complicated subject. The unethical practices of guest, honorary, andghost authorship and incomplete or biased disclosure of clinical trialdata have led to guidelines meant to…

Writing for medical devices compared to pharmaceuticals: An introduction - Volume 26, Issue

Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…

RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…

Odd cases and risky cohorts: Measures of risk and association in observational studies - Volume 26, Issue

Hundreds of statistical tests, procedures, and descriptive measures are used in clinical research. Risks, odds, and hazards are among the most common but not always the most understood. They are often used in all three types of observational studies…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

The joys of outlining in medical writing - Volume 21, Issue

Using an outline to organize your writing project can help keep you on a straight path and avoid wandering into wastelands of irrelevance. There are various formats – the classic hierarchal model, the IMRAD system used for research reports, the…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

Statistical principles in biosimilar development - Volume 28, Issue

Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…

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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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