Medical Writing Writing for Patients Pharmaceutical clinical trials transparency and privacy
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Volume 29, Issue 4 - Writing for Patients

Pharmaceutical clinical trials transparency and privacy

Abstract

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors to reveal trial results to participants and patients, physicians, and independent researchers. Since then, more requirements have emerged, including anonymisation and publication policies introduced by the EMA and Health Canada. Going beyond regulatory compliance, transparency leaders have launched voluntary data-sharing initiatives to enable researchers’ access to structured individual patient data. With this move toward greater transparency and the drive for more data, transparency functions working with the clinical trials environment need a broader toolkit of capabilities, including anonymisation, to protect participants’ privacy. The authors explored these emerging trends in a webinar for FDANews on July 23, 2020 (https://www.fdanews.com). FDANews has an 80,000-person database, mainly from the clinical trial space. This article summarises the webinar.

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Articles

Editorial - Writing for Patients
Editorials - Passing the Torch: The Sequel/Filling Big Shoes
Foreword: Writing for Patients, Foreword from the EMA
President's Message
EMWA News
Promoting equity in understanding: A cross-organisational plain language glossary for clinical research
Medical abbreviations with multiple meanings: A prescription for disaster
Writing for patients: When and how?
Lay summaries for Phase 1 trials in healthy volunteers
Participant information – an ethics committee view
Establishing a patient publication steering committee: A case study with insights for medical writers
Translation: A transcultural activity
Writing for the internet
Social Media: A tool that can benefit public health?
Partnering with patient associations: Engaging medical writers to support health literacy for patients
Pharmaceutical clinical trials transparency and privacy
News from the EMA
Medical Devices
Regulatory Matters
In the Bookstores
Good Writing Practice
My First Medical Writing
Getting Your Foot in the Door
Out on Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk