Medical Writing Real-World Data, Real-World Evidence

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Volume 34, Issue 3 - Real-World Data, Real-World Evidence

September 2025

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Editorial

Real-world data and real-world evidence: A new ethics of knowing

Authors: Laura C. Collada Ali, Maria Kołtowska-Häggström

From the Editor

Author: Raquel Billiones

President's Message

President's Message

Author: Martin Delahunty

EMWA News

EMWA News

Author: Somsuvro Basu

Feature Articles

Real-world evidence and real-world data in contemporary healthcare: A critical overview

Author: Andrew Balkin

Real-world data and evidence: A European regulatory perspective

Author: Somsuvro Basu

From data to impact: Exploring the evolution of real-world evidence at the FDA

Authors: Shadaab Ayub, Scott Swain

Expanding the safety horizon: How real-world evidence shapes drug safety

Authors: Andrew Balkin, Maria Kołtowska-Häggström

Defining the quality of data within rare disease registries: A systematic review

Authors: Jessica Anderson, Malika Alimussina, S. Faisal Ahmed

Lessons learnt from PETHEMA’s RWD research: A clinical perspective

Authors: Alfonso Santiago-Marí, Irene Salcedo-Marín, Roberto Maldonado, Carmen López-Carrero, David Martínez-Cuadrón, Pau Montesinos

Real-world data in clinical development: Statistical considerations and reporting challenges

Authors: Natasa Rajicic, Anders Mattsson, Maria Kołtowska-Häggström

Embracing the potential of real-world data: An industry perspective

Authors: Anna Woziwodzka, Wendelgard Pisternick-Ruf, Anouk Déruaz-Luyet

The role of real-world evidence in post-market clinical follow-up

Authors: Laura C. Collada Ali, Kelly Goodwin Burri, Katharina Friedrich

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

Authors: Gomathi Priya Jeyapal, Prarthana Vigneshwari Reddy, Vrushabh Baburao Satav, Pattabhi Machiraju

Real-world evidence: What does the medical writer need to know?

Authors: Harriet S. Crofts, Sarah J. L. Graham

Artificial intelligence and machine learning in real-world evidence: Transforming data into actionable insights

Authors: Pattabhi Machiraju, Hemalatha Jayapalan, Giles Devasahayam, Manjari Deshmukh

The paradigm of real-word evidence in lifestyle medicine: Insights, considerations, and opportunities for medical writers

Authors: Maria Carolina Rojido, Mariana Rickmann, Laura A. Kehoe

Silenced data: How banning words undermines real-world evidence in medical writing

Authors: Giovanna Gelmi, Claudia Percivalle

News from the EMA

News from the EMA

Author: Anuradha Alahari

Regular Sections

Medical Communications and Writing for Patients

Authors: Lisa Chamberlain James, Veronica K. Contreras

Regulatory Matters

Authors: Clare Chang, Zuo Yen Lee, Jenni Pickett, Vanessa de Langsdorff

Medical Devices

Authors: Payal Bhatia, Crispin Bennett, Heidi Chapman, Laura C. Collada Ali

My First Medical Writing

Authors: Evguenia Alechine, Janaine Prata de Oliveira

Gained in Translation

Gained in Translation

Authors: Ana Sofia Correia, Ekaterina Chashnikova

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Scope

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.

Medical Writing is listed in the following indexes:

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Senior Editor

Victoria White

Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Nicole Bezuidenhout

Barbara Grossman

Sampoorna Rappaz

Section Editors

AI/Automation

Biotechnology

Nicole Bezuidenhout

Digital Communication

EMWA News

Freelancing

Ana Sofia Correia

Gained in Translation

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / Alison McIntosh

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Tiziana von Bruchhausen

Pharmacovigilance

Clare Chang / Zuo Yen Lee

Regulatory Matters

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Layout Designer

Chris Monk