Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Creative medical writing: An oxymoron? - Volume 27, Issue

According to the Merriam-Webster Dictionary, creativity is “the ability to create”, and to create means “to make or bring into existence some - thing new”.1As it applies to writing, creativity is most often associated with imaginative, fictional…

Medical Education - Volume 25, Issue

Medical education implies providing education or training of unbiased scientific or medical content. However, the reality is that medical education is now more a spectrum of educational activities that span from more promotional to purely…

Medical Communications and Writing for Patients - Volume 28, Issue

The more eagle eyed among you will have noticed that we are changing the title of this section to “Medical Communications and Writing for Patients”. Not the shortest of titles, I know, but hopefully it is a more accurate reflection of the content…

Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature - Volume 25, Issue

This interview provides solutions to some of the common pitfalls that face medical writers when working with large teams. Practical tips are provided on key topics including manuscript planning, agreeing on key messages and the use of figures,…

Perspective from a leading scientific author: An interview with Professor Ruth Roberts on authors and authoring - Volume 25, Issue

This interview provides solutions to some of the common pitfalls that face medical writers when working with large teams. Practical tips are provided on key topics including manuscript planning, agreeing on key messages and the use of figures,…

Three strategies to help you write clearly for a lay audience - Volume 26, Issue

When writing health and medical content for a lay audience, it is important to think beyond simply writing well. Defining your ideal readers, reducing medical jargon, and producing a well-formatted piece of work  can all enhance your reader’s…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…

Patient education accessibility - Volume 24, Issue

Patient education that overcomes literacy barriers supports quality care. This article provides an overview of health literacy, describes the concepts of readability and accessibility, and discusses how to empathise with the patient's experience and…