To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…

News from the EMA - Volume 33, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive.

Medical Writing. 2024;33(3):72–78.

News from the EMA - Volume 33, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. Medical Writing. 2024;33(4):68–70.

News from the EMA - Volume 34, Issue

The items included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. Medical Writing. 2025;34(1):60–65.

In vitro plants: How to open a jar containing bioactive phytochemicals - Volume 32, Issue

Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

How FAIR are pharma publication data? - Volume 31, Issue

Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Purr-fecting translation: Unleashing the power of computer-assisted translation (CAT) tools Author: Natasha Grande de França Medical translations are fundamental, and precision is at the core of this work. Any…

Abstracts from the 57th EMWA Conference Poster Session - Volume 33, Issue

EMWA’s spring conference in Valencia featured 18 posters on a wide variety of topics of interest to medical writers. Clinical trial regulations, plain language summaries, graphical abstracts, and document quality control are just a few of the…

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…