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Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Lay summaries and writing for patients: Where are we now and where are we going? - Volume 28, Issue

We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…

Can access and accessibility rebuild public trust in research? - Volume 31, Issue

Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Getting Your Foot in the Door - Volume 30, Issue

No setback comes without a blessing Like many things in the professional world, I got to know more about medical writing and see it as the next step in my professional life, thanks to a connection. A friend of a friend was a native Spanish speaker…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

Establishing a patient publication steering committee: A case study with insights for medical writers - Volume 29, Issue

Development of a patient publication steering committee (PPSC) is an innovation in industry publication practices. In this brief article, we summarise how UCB Pharma, a global biopharmaceutical company, plans to partner with patients to establish a…

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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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