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The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
Randomised controlled trials are the gold standard for evaluating the efficacy of medical interventions, offering robust evidence through controlled designs that minimise bias. However, their generalisability to diverse patient populations is typical…
Executive orders (EOs) issued by the President of the United States can significantly shift federal research priorities, funding allocations, and public health directives, thereby influencing which medical topics receive attention and resources. EOs…
The production of high-quality graphical figures of scientific data is an important aspect of medical writing, since the significance of the research findings can be lost to the audience if the data are presented poorly or inaccurately. This…
With scientific advances during the COVID- 19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase h…
The healthcare industry has witnessed a significant shift towards the use of real-world data (RWD) and real-world evidence (RWE) in medical decision-making and treatment evaluation. This article explores the importance of RWE in healthcare…
In recent years, the healthcare industry has experienced an exponential growth in the volume of real-world data (RWD) due to advancements in digital health, electronic health records (EHR), wearables, and other data-generating technologies. The…
A goal for all diseases is a treatment that works to prevent, halt, or reverse their effects – essentially, a cure. Achieving this requires early diagnosis, knowledge of disease mechanisms, and effective treatment. For rare diseases, each of these…
A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…
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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