Out on Our Own - Volume 25, Issue

In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

News from the EMA - Volume 30, Issue

Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…

Biotechnology - Volume 31, Issue

This is the first Medical Writing Biotechnology regular section. Biotechnology is a broad subject. It can be defined by the use of biological systems and living organisms in production processes. Biotechnology has been around for thousands of years.…

In the Bookstores - Volume 25, Issue

In The Elements of English Editing: A Guide - line to Clear Writing, authors Lee Ann Weeks and Ann Bless have combined their 50 years of experience to create a concise, 71-page book which introduces readers to the language editing process. This book…

Medical Writing Teaching - Volume 25, Issue

Teaching manuscript writing in Africa I’m glad to have the opportunity to contribute to this new regular feature in MEW – ’Teaching medical writing’. Why write about teaching in Africa? Well, Claire Gudex – who will manage the section – thought my…

Veterinary Medical Writing - Volume 30, Issue

This edition of Veterinary Medical Writing signals a changing of the guard as Karim Montasser passes on the reins, having guided this section of Medical Writing with a steady hand during his tenure. And it is mindful of those auspicious shoes to…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

Veterinary Medical Writing - Volume 30, Issue

The placebo-by-proxy effect – another argument against homeopathy

Chances are you know about the placebo effect. There are many variables to study,1 but in general, the placebo effect means that if you believe in a positive outcome of a drug, you wi…