Medical Writing Writing for Patients Lay summaries for Phase 1 trials in healthy volunteers
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Volume 29, Issue 4 - Writing for Patients

Lay summaries for Phase 1 trials in healthy volunteers

Abstract

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the majority of substances tested in Phase I never reach the market. Nevertheless, the European Union Clinical Trials Regulation (EU CTR) mandates that lay summaries are to be provided for all clinical trials regardless of clinical phase. As lay summaries are intended to inform the public about the results of clinical studies, they need to be understandable to people without specific knowledge of the disease or the clinical research process. It is challenging to write lay summaries for Phase I trials that are both meaningful for the public and in line with the requirements of the EU CTR. We have developed a template to facilitate writing of lay summaries of Phase I trials in healthy volunteers. Using a template ensures that study designs and endpoints are described in a consistent lay-friendly manner across different types of Phase I trials.

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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

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

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

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk