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Insulin biosimilars - Volume 28, Issue

Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1,…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Troublesome words - Volume 26, Issue

Medical writing tends to contain longer, less common, words than English fiction, and they are here termed troublesome words. Troublesome words are an indicator of poor style, and often point to grammatical errors. An easy way to start improving…

ICMJE requirements for sharing individual participant data from interventional clinical trials - Volume 28, Issue

Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…

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…

Editorial: Pharmaism - Volume 22, Issue

Criticising the pharmaceutical industry is a type of sport, and it is astonishing what nonsense people will believe about it. For example, it has been said that pharmaceutical companies will only conduct a clinical trial against another product that…

Science writing workshops for AIDS vaccine researchers in Africa - Volume 22, Issue

The International AIDS Vaccine Initiative (IAVI) is a global scientific and advocacy organisation dedicated to ensuring an AIDS vaccine for use worldwide. In Africa, IAVI partners with seven research centres who conduct vaccine trials and studies.…

AuthorAID: An international service and chance to serve - Volume 22, Issue

Medical and other researchers in developing countries conduct much valuable research. Yet difficulties in writing and publication often prevent this research from being widely known. AuthorAID (http://www.authoraid.info), a project of the…

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

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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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