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Unlocking the potential of patient data through responsible sharing – has anyone seen my keys? - Volume 29, Issue

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…

The regulatory-HTA decision-making interface: What the medical writer should know - Volume 30, Issue

For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…

Profile: An interview with Blanca Mayor Serrano on the state-of-the-art of health literacy in Spain - Volume 22, Issue

There seems to be a move towards ‘patient-centred’ health care as part of an overall effort to improve the quality of health care and to reduce costs. Individual patients and providers have to work together to ensure effective communication.…

Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

From algorithms to insights: The role of medical writers in AI-enhanced real-world evidence - Volume 34, Issue

Real-world evidence (RWE) complements randomised controlled trials (RCTs) by assessing treatment effectiveness in diverse populations. Integrating artificial intelligence (AI) and machine learning (ML) enhances RWE by enabling predictive modelling,…

The role of real-world evidence in post-market clinical follow-up - Volume 34, Issue

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements, methodologies, and…

Clinical trial disclosure and transparency - Volume 27, Issue

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…

Report on the EMA Workshop on clinical trial data and transparency - Volume 22, Issue

Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…

Regulatory Matters - Volume 30, Issue

Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…

Potential implications of wider data transparency in medical communications - Volume 22, Issue

The current medical communication environment is characterised by growing calls for increased data transparency. There are ongoing concerns about the selective publication of trial results and the potential impact on use of medicines by prescribers…

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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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