GSK gives update on plans to share detailed clinical trial data as part of its commitment to transparency

  • New online system will enable researchers to request access to patient level data from GSK clinical trials to help further scientific understanding and improve patient care
  • Panel of independent experts will review research proposals for access to anonymised patient level data
  • First step towards the ultimate aim of broader system in which data from multiple organisations are made available for research through an independent data custodian

 

Issued: Tuesday 7 May 2013, London UK

GlaxoSmithKline (GSK) today announced progress on its commitment to share more detailed data from its clinical trials. A new online system available on gsk.com (https://clinicalstudydata.gsk.com/) will enable 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.

Consistent with expectations of good scientific practice, researchers can 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 provided on a password protected website to help protect research participants’ privacy and ensure the data are used for the approved scientific purpose.  

This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers are able to access data from clinical trials conducted by multiple organisations. This system would be run by an independent third party who would be responsible for appointing and overseeing a review panel to assess research proposals. GSK is already in discussions with interested parties to encourage the development of such a system.

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.”  

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.

GSK has taken a number of steps over the years to share more information from clinical trials that evaluate its medicines:

  • The company registers and posts summary information about each clinical trial it begins.
  • Results of all clinical trials – whether positive or negative – are made available on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month.
  • The company has also committed to seek publication of the results of all of its clinical trials that evaluate its medicines in peer-reviewed scientific journals.
  • Most recently, in February 2013, GSK signed up to the AllTrials campaign for clinical data transparency and committed to make its clinical study reports (CSRs) publicly available through its clinical trials register after approval, termination and publication. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to regulatory agencies.

Members of the current independent review panel

Brian L. Strom MD (Chairman)

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, United States

Marc Buyse ScD

Associate Professor of Biostatistics, Hasselt University Belgium and Founder, International Drug Development Institute, United States

Bartha Maria Knoppers PhD

Canada Research Chair in Law and Medicine and Director of the Center of Genomics and Policy, McGill University, Canada

John Hughes

Patient and Public Involvement member of the UK Clinical Research Collaboration Board, UK

 

Further information about panel members is available on the online system

 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

 

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.