Medical Writing Writing for Patients Lay summaries for Phase 1 trials in healthy volunteers

Volume 29, Issue 4 - Writing for Patients

Lay summaries for Phase 1 trials in healthy volunteers


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.

Download the full article



Editorial - Writing for Patients
Editorials - Passing the Torch: The Sequel/Filling Big Shoes
Foreword: Writing for Patients, Foreword from the EMA
President's Message
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

Member Login


The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board



Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: