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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.
The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…
We all know there is nothing trivial about clinical trials. But let’s have some light fun and the try answering the short quiz about the topic.
Medical Writing. 2023;32(1)53, 65
EditorialSection Editor: Kimi Uegaki Growing and nurturing a grassroots sustainability team in a clinical centre Authors: Sarah Kabani, Virginie Chasseigne, Sihame Chkair Medical Writing. 2023;32(4):87–89. https://doi.org/10.56012/wynp1520
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
Bad Pharma is the latest book by the well-known anti-quackery campaigner Ben Goldacre, and attempts to explain to us that medicine is broken. Despite the title, he criticises not only the pharmaceutical industry, but also regulators, doctors,…
The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…
EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to…
Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…
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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