Medical Writing Clinical Trials
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Volume 32, Issue 1 - Clinical Trials

March 2023

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Editorial

Editorial
Authors: Raquel Billiones, Ivana Turek

President's Message

President's Message
Author: Satyendra S. Shenoy

EMWA News

EMWA News
Author: Somsuvro Basu

Feature Articles

Bringing decentralised clinical trial protocols to life
Author: Jonathan Mackinnon

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists
Authors: Kishor P. Patil, Chandra Kumar, Siu-Long Yao

Transition to the EU Clinical Trials Regulation: Trick or treat?
Author: Ivana Turek

The Lay Protocol Synopsis: Requirements and feasibility
Author: Lisa Chamberlain James

Lay titles for clinical trials: Is industry achieving the balance?
Authors: Leonie H.E. Leithold, Clive M. Brown, Julia A. Hild, Thomas M. Schindler

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting
Author: Zuo Yen Lee

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective
Authors: Sarah Milner, Andrew R. Kusmierczyk, Julie Taccoen

Clinical Investigations for Medical Devices
Authors: Beatrix Döerr, Shirin Khalili, Joan D’souza

Clinical Trials in the Eurasian Economic Union
Authors: Eugenia Radkova, Irina Petrova

Clinical study reports: A snapshot for aspiring medical writers
Author: Surayya Taranum

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials
Authors: Tatiana Revenco, Gregory Collet

Connecting the dots across the writing continuum
Author: Ambika Subramanian

News from the EMA

EMA Foreword
Authors: Morgane Colin de Verdiere, Catriona Ester

Special Section

Trial Trivia
Author: Raquel Billiones

Regular Sections

News from the EMA
Author: Anuradha Alahari

Teaching Medical Writing
Authors: Joanna Verran, Sam Illingworth, James Pritchett, James Redfern, Claire Gudex

Regulatory Public Dislcosure
Author: Sam Hamilton

In the Bookstores
Authors: Alison McIntosh, Stephen Gilliver

Veterinary Medical Writing
Authors: Rhona Fraser, Louisa Marcombes

Lingua Franca
Authors: Christa Bedwin, Maria Kołtowska-Häggström

Good Writing Practice
Authors: Michael Lewis Schneir, Wendy Kingdom, Amy Whereat

Pharmacovigilance
Authors: Ernest Dela Dzidzornu, Jerin Jose Cherian, Joan D’souza, Jayesh M. Pandit, Melissa Bernal, Diana Radovan, Tiziana von Bruchhausen

Regulatory Matters
Authors: Arunon Sivananthan, Zuo Yen Lee, Clare Chang

The Crofter: Sustainable Communications
Authors: Kim Thomas, Kimi Uegaki

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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

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Adriana Rocha

Freelancing

Ana Sofia Correia 

Gained in Translation

Ivana Turek

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

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

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

Sam Hamilton

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk