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Clinical writing, a specialised type of medical writing, refers to the types of writing health professionals use on a daily basis such as medical charts and forms. It requires knowledge of both formal and informal medical language and culture. An…
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,…
The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers…
More and more clinical studies are taking place in Russia, making it an attractive market for medical writing. In 2011, the Ministry of Healthcare of the Russian Federation approved over 550 new clinical studies of all types, a 16% increase over the…
The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…
To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…
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…
This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…
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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