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A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…
EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…
Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…
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…
Multivariable analyses are some of the central statistical methods of clinical trials, and yet some medical writers may be unsure as to what they are and how best to interpret and report the results. In this article we provide an overview of…
Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…
The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…
Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
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…
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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