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Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
Syntactic Structure - Inter-sentenceIncrementalism: SentencesInter-sentence incrementalism is an expansion of information, often secondary, into a sentence rather than a reduction of the information to a clause or phrase and incorporation (sentence…
The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…
The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…
Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…
A look forward – and back! - at AI in Medical Writing This issue of Medical Writing is devoted to automation and artificial intelligence (AI), the hot topic that interests all of us and that is likely to change our lives dramatically, at least our…
Successive waves of COVID-19 have altered opinions and working practices. We conducted a survey in early 2020 among 759 members of the medical communications community, recruited via our network, seeking their experiences, opinions, and insights.…
This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…
Uncertainty is an unavoidable problem when analysing health technology assessment results, which can make decision making difficult. Whilst we have ways of presenting uncertainty for individual outcomes in a systematic review, we do not have 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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