Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

Regulatory Matters - Volume 29, Issue

Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…

Foreword: Writing for Patients, Foreword from the EMA - Volume 29, Issue

In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

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…

Good Writing Practice - Volume 30, Issue

Grammatical misagreement in tense

I – Present, present perfect

Introduction

Each of the sections of a journal article contains anticipated conceptual components, which can be expressed by a specific verb tense for the perspective of time and the d…

Unlocking the power of emotional intelligence in medical writers - Volume 33, Issue

Emotional intelligence (EI), the ability to recognise and understand emotions (one’s own and those of other people), is a valuable attribute for medical writers (MWs). MWs play a pivotal role in communicating medical and scientific information to…

Towards electronic product information that meets the needs of everyone: Implications for patients, clinicians, and medical writers - Volume 34, Issue

In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…

Advances in the CRISPR-Cas9 system and gene therapy - Volume 32, Issue

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…

Medical Devices - Volume 27, Issue

The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…