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The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

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…

Patient-reported outcomes: How useful are they? - Volume 26, Issue

Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Why clinical study reports really matter - Volume 27, Issue

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of  the statistical analysis. A…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Guidelines for disclosing the results from observational trials - Volume 26, Issue

Observational trials are a relevant part of clinical research. Publishing their results can be challenging for scientists and writers.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement was the first…

Statistical analyses and methods in the published literature: The SAMPL guidelines - Volume 25, Issue

Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…

How to write about coronavirus: Best practices for health writers - Volume 30, Issue

FOCUS ON FACTS AND EVIDENCE-BASED REPORTING 

what we know, not what we think might happen

AVOID FEAR-MONGERING

watch your language

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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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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

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Jennifer Bell

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Nicole Bezuidenhout 

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Somsuvro Basu

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Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

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In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

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Payal Bhatia

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My First Medical Writing

Anuradha Alahari

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Clare ChangZuo Yen Lee 

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Sam Hamilton

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Phil Leventhal

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