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Your search for "clincial trial data" matched 63 page(s).

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Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

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…

Study design made easy - Volume 25, Issue

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

From algorithms to insights: The role of medical writers in AI-enhanced real-world evidence - Volume 34, Issue

Real-world evidence (RWE) complements randomised controlled trials (RCTs) by assessing treatment effectiveness in diverse populations. Integrating artificial intelligence (AI) and machine learning (ML) enhances RWE by enabling predictive modelling,…

Medical writing around the world - Volume 22, Issue

As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…

Medical writing education - Volume 22, Issue

Although medical writing as a career has been around for a few decades, medical writing education is relatively new. Many medical writers end up teaching scientific or medical writing, and have built their courses and their teaching style without…

President's Message - Volume 24, Issue

I can't believe that my two years on the Executive Committee are now complete – what a journey from Manchester and Barcelona in 2013, Budapest and Florence in 2014, and finally Dublin in 2015. Apart from travelling many miles, I have had a great…

Oncology and medical writers - Volume 21, Issue

Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that…

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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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