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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.
Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…
Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…
There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical…
Guidelines for Reporting Health Research: A User’s Manual By David Moher (Editor), Douglas Altman (Editor), Kenneth Schulz (Editor), Iveta Simera (Editor), Elizabeth Wager (Editor) Wiley Blackwell, 2014. ISBN: 978-0-470-67044-6 (paperback) 32.99…
The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
This article describes the development and use of quality patient decision aids to support patient involvement in making healthcare decisions. Briefly, patient decision aids should provide at least information on options, benefits, and harms, and…
How results are reported influences how they are interpreted. Although P values have been granted great importance, they have no clinical interpretation. Rather, they are a measure of chance as an explanation for the results. Their either or…
While plagiarism of others’ work is universally condemned, authors’ reuse of their own words and data (so-called ‘self-plagiarism’) is a far more contentious issue. The recycling of one's own text, in particular, polarizes opinion: some consider it…
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…
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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