Medical Writing The Data Economy Unlocking the potential of patient data through responsible sharing – has anyone seen my keys?

Volume 29, Issue 2 - The Data Economy

Unlocking the potential of patient data through responsible sharing – has anyone seen my keys?

Abstract

The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately consented and deidentified participant-level data and associated clinical documents is an expectation of key research funders, journal editors, pharma ceutical trade associations, regulators, ethics committees, and government entities sponsoring research. Furthermore, patients increasingly support expanded data sharing to help spur innovation and maximise the utilisation of data gathered during clinical studies. Finally, rapidly and appropriately leveraging real-world data to support and validate clinical research data and to facilitate responses to emerging public health emergencies lends greater importance and urgency to finding better ways to unlock and share health data. This article provides an overview of the current state of participant-level data sharing in clinical research and a discussion of the opportunities that exist to better navigate barriers to access whilst respecting the data privacy rights of study participants. This article describes our collective journey through the data sharing ecosystem, looking to further unlock the value of study participant data to drive new discoveries.

Download the full article

Search

Articles

Editorial
The data economy: A glossary
Presidents' Messages
EMWA News
EMWA’s newest special interest group: Sustainability SIG
Rush to publication – What do we have to lose?
The value of registry data in the clinical evaluation of medical devices
Big data in clinical research: Present and future
Leveraging standardised data in response to the novel coronavirus outbreak
Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries
The new value of clinical data in Europe
Unlocking the potential of patient data through responsible sharing – has anyone seen my keys?
COVID-19 contagion, information, and misinformation
"Processing health-related data for scientific research: Is consent an appropriate legitimate ground?"
An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group
A role for medical writers in overcoming commonly held misconceptions around FAIR Data
MyData: Applying human-centric principles to health data
Thriving in the data economy as data-fluent PhD graduates
Digital identifiers in scientific publishing and e-health
Winners of the Geoff Hall Scholarship Essay Competition
News from the EMA
Regulatory Matters
Regulatory Public Disclosure
Medical Devices
Getting your Foot in the Door
Journal Watch
Veterinary Medical Writing
Good Writing Practice
Out on Our Own

Member Login

Links

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

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