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.
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk