GSK outlines plan to share clinical trials data

Published: 8-May-2013

Appoints an external independent panel of experts to advise on development of the online system


GlaxoSmithKline (GSK) is to establish a new online system that will grant researchers access to patient level data from the firm’s clinical trials.

This comes after the UK pharmaceutical firm signed up to the AllTrials campaign in February, signalling its commitment to clinical data transparency.

GSK’s new system, available at https://clinicalstudydata.gsk.com/, goes further than the AllTrials scheme by allowing researchers to request access to anonymised patient level data that sit behind the results of clinical trials.

It is hoped that sharing these data with researchers will help to further scientific research, increase understanding of new and current medicines and ultimately improve patient care, says GSK.

Researchers can request access by providing a scientific protocol with a commitment to publish their findings.

GSK has appointed an external independent panel of experts to advise on the development of the system.

The independent review panel includes:

  • Brian Strom, George S Pepper Professor of Public Health and Preventive Medicine, Professor of Biostatistics and Epidemiology, and Executive Vice Dean for Institutional Affairs, Perelman School of Medicine, University of Pennsylvania, US, who will be the panel’s chairman;
  • Marc Buyse, Associate Professor of Biostatistics, Hasselt University Belgium and Founder, International Drug Development Institute, US;
  • Bartha Maria Knoppers, Canada Research Chair in Law and Medicine and Director of the Center of Genomics and Policy, McGill University, Canada; and John Hughes, Patient and Public Involvement member of the UK Clinical Research Collaboration Board, UK.

Access to the data from GSK's studies will be provided on a password-protected website to help protect research participants' privacy and ensure the data are used for the approved scientific purpose.

An independent third party would run the system, and be responsible for appointing and overseeing the review panel to assess research proposals. GSK is already in discussions with interested parties to encourage the development of such a system.

We are absolutely committed to sharing data so that researchers can examine the details more closely

Patrick Vallance, GSK's President of Pharmaceuticals R&D, said: ‘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.

‘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.’

The studies will be listed on GSK's system once a medicine has been approved by regulators or terminated from development and the study has been accepted for publication. Studies that do not progress to publication will also be included.

The system already includes global studies conducted since 2007. Over the next two years global studies going back to the formation of GSK in December 2000 will be added. In addition, all studies (including local studies) starting in or after 2013 will be included.

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