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Impact of protocol amendments, bias and quality in industry-funded trials, and rethinking authorship criteria Amendments to clinical trial protocols are widespread, but can result in increased costs and delays in study implementation.
Authorship, ghostwriting, and tips on making scientific writing more enjoyable to read In this issue five papers are discussed covering the subjects of authorship and authorship criteria, ghostwriting and guest authorship, and adding style to…
The vast majority of investigator brochures lack sufficient information to systematically appraise the strength of the supporting pre clinical findings
The one sentence summary of a paper signed by 72 statisticians was: “We propose to change the default P-value threshold for statistical signifi - cance for claims of new discoveries from 0.05 to 0.005”.1 The proposal is straightforward, but it must…
We need more recommendations to report adverse events in publications
A novel proposal for article discussion sections
A proposal to define a new category of bad practice – The non-publication of clinical trial results
Medical writers commonly are hired to write for traditional journals targeting the highest possible impact factor. However, as medical writers, we should be aware of alternative options. In September last year, I had the pleasure to meet Michael…
Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…
This joint position statement of the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) describes the appropriate role of…
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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