GSK Announces Plans to Share Clinical Trial Data - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

GSK Announces Plans to Share Clinical Trial Data

In its commitment to transparency, GlaxoSmithKline (GSK) has outlined plans to share detailed data from its clinical trials. GSK is to establish a new online system that will enable researchers to request access to anonymised patient level data.

This move marks the first step towards the ultimate aim of the clinical research community developing a broader system where researchers can access data from clinical trials conducted by multiple organisations. It is hoped that data sharing in such a way will help advance scientific research, increase understanding of new and current medicines and ultimately improve patient care.

Researchers will be able request access by providing a scientific protocol with a commitment to publish their findings. External independent experts appointed by GSK to advise on the development of the system will be the initial review panel, responsible for assessing research proposals made through the system. Access to the data from GSK’s studies will be granted on a password protected website to protect research participants’ privacy and to ensure that the data are used for the approved scientific purpose.

"When people volunteer for clinical trials, they expect that the results will be used to help others. We are absolutely committed to sharing data so that researchers can examine the details more closely, do their own analyses and learn more about medicines and how they can best be used. Consistent with good scientific practice, researchers will be required to submit a research plan and to commit to transparency in the publication of their work, " said Patrick Vallance, GSK’s president of pharmaceuticals R&D, in a press statement.

"We are the first organisation to develop a system for sharing detailed clinical data in this way. Now we want to see this initiative transition to a broader independent model that brings together data from multiple organisations. We are keen for this to progress and hope such a system can be put in place by a third party in the public or charitable sector as soon as possible, " Vallance added.

GSK has already begun discussions with interested parties to encourage the development of such a system. Studies will be listed on the online system once a medicine has been approved or terminated from development and the study has been accepted for publication. Studies that do not progress to publication will also be available. Global studies conducted since 2007 have already been included in the system and those dating back to the formation of GSK in December 2000 will be added over the next two years.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Click here