Medical Writing Clinical Trials Bringing decentralised clinical trial protocols to life
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Volume 32, Issue 1 - Clinical Trials

Bringing decentralised clinical trial protocols to life

Abstract

Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and repli cability in clinical trial protocols incorpora ting DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.

Medical Writing. 2023;32(1)12-18. https://doi.org/10.56012/rtqr5570

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Articles

Editorial
President's Message
EMA Foreword
EMWA News
Bringing decentralised clinical trial protocols to life
Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists
Transition to the EU Clinical Trials Regulation: Trick or treat?
The Lay Protocol Synopsis: Requirements and feasibility
Lay titles for clinical trials: Is industry achieving the balance?
To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting
The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective
Clinical Investigations for Medical Devices
Clinical Trials in the Eurasian Economic Union
Clinical study reports: A snapshot for aspiring medical writers
Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials
Connecting the dots across the writing continuum
Trial Trivia
News from the EMA
Teaching Medical Writing
Regulatory Public Dislcosure
In the Bookstores
Veterinary Medical Writing
Lingua Franca
Good Writing Practice
Pharmacovigilance
Regulatory Matters
The Crofter: Sustainable Communications

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

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 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk