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Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer - Volume 23, Issue

One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…

Clinical trial disclosure and transparency - Volume 27, Issue

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…

Non-clinical health writing - Volume 23, Issue

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…

Clinical trial transparency and disclosure from the medical writing perspective - Volume 33, Issue

It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

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…

Writing biosimilar clinical study reports and submission documents – what to expect and what to consider - Volume 28, Issue

With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…

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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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