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A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…
Like many medical writers, I started in another career first. For me, it was practising veterinary medicine in a clinic, then going into clinical research in humans, and then on to medical writing. Designing clinical trials, sample size…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…
In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…
This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…
This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…
Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…
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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