Medical Writing Clinical Trial Transparency and Disclosure

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Volume 33, Issue 3 - Clinical Trial Transparency and Disclosure

September 2024

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Editorial

Clinical trial transparency and disclosure from the medical writing perspective

Authors: Holly Hanson, Alison McIntosh

From the Editor

Author: Raquel Billiones

President's Message

President’s Message

Author: Sarah Tilly

EMWA News

EMWA News

Author: Somsuvro Basu

Feature Articles

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules"

Authors: Merete Jørgensen, Kathy B. Thomas, Matthias Zerm, Robert A. Paarlberg

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another

Authors: Mirjana Miric, Sarah Bly

Navigating the complex landscape of clinical trial transparency: What medical writers need to know

Authors: Pooja Phogat, Stuart Donald

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved?

Author: Lisa Chamberlain James

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community

Authors: Zuo Yen Lee, Alison McIntosh, Vivien Fagan, Sam Hamilton

Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age

Authors: Devaki Thavarajah, Sylvia Baedorf Kassis, Alyssa Panton, Barbara E. Bierer, Trishna Bharadia

Publisher perspectives on plain language summaries of scientific publications: An Open Pharma survey

Authors: Slavka Baronikova, Adeline Rosenberg, Christopher C. Winchester, Valérie Philippon, Jo Gordon, Joana Osório

Medical writing in Italy in 2024: Results of the first Italian business and compensation survey

Authors: Daniela Longo, Johanna M. Chester, Laura C. Collada Ali, Andrea Rossi

News from the EMA

News from the EMA

Author: Anuradha Alahari

Regular Sections

Digital Communication

Authors: Nicole Bezuidenhout, Jacqueline Bersano

Medical Communications and Writing for Patients

Authors: Lisa Chamberlain James, Aki Yoshikawa, Atsuko Iwata, Miho Hatano, Yuko Kojima

Regulatory Public Disclosure

Author: Sam Hamilton

In the Bookstores

Authors: Alison McIntosh, Pablo Izquierdo

Publications

Author: Maddy Dyer

The Crofter: Sustainable Communications

Authors: Louisa Ludwig-Begall, Sarah Kabani

Good Writing Practice

Authors: Wendy Kingdom, Amy Whereat, Michael Lewis Schneir

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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

Managing Editor

Victoria White

Deputy 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