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Preventing biomedical research waste - Volume 31, Issue

An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…

ICMJE requirements for sharing individual participant data from interventional clinical trials - Volume 28, Issue

Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

Preclinical studies - Volume 26, Issue

Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…

Preparing the Paediatric Investigation Plan application - Volume 21, Issue

In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Medical Communications - Volume 26, Issue

Dear all,In this issue, Rossella Ferrari tackles the elephant in the room – how do medical writers manage to find time for their continuing professional development whilst still keeping their head above water with their ongoing project work?We all…

Lingua Franca and Beyond - Volume 25, Issue

In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…

HTA decision-making: Do ethics matter? - Volume 30, Issue

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys - Volume 31, Issue

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.…

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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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