GSK adds detailed clinical trial data to multi-sponsor request system as part of continued commitment to data transparency

Issued: London UK

GlaxoSmithKline (GSK) has added its anonymised patient-level data from the online request system it launched in May 2013 to a new multi-sponsor request system (clinicalstudydatarequest.com) that includes studies from multiple organisations.

Last year GSK became the first company to launch an online system enabling external researchers to request access to the detailed data that sit behind its clinical trial results. More than 450 studies have now been made available on the new site. GSK’s patient-level data transparency commitments remain unchanged through the new multi-sponsor request system:

• GSK is continuing to post studies going back to the formation of GSK in 2000.
• Studies are made available 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).
• Researchers can ask about the availability of data they are interested in from studies not yet listed on the site.
• The arm’s length review panel who have been reviewing proposals through GSK’s site since May 2013 will continue its role and will now review proposals that include studies from other sponsors. Up to 30 November 2013, 16 requests for data had been received by the review panel. 12 requests had been approved, with four being processed. None had been turned down.

GSK will regularly add studies to the site. The next major update, when additional new and historic studies will be added, is planned for Q1 2014.

James Shannon, GSK’s Chief Medical Officer, said: “Our commitment to transparency of clinical trial data reflects our wish to help advance scientific understanding and enable the scientific community to learn from the research we have undertaken. Enabling researchers to request the studies they are interested in from multiple organisations through one system will, we hope, help further research.

“Our ultimate aim remains unchanged and that is to see a broad system developed that brings together data from many organisations and is also run by an independent third party who would be responsible for managing the review of research proposals. This initiative is an important step towards that aim.”

Notes

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.
• 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.
• In May 2013 GSK became the first organisation to launch an online system enabling external researchers to request access to anonymised patient-level data from its clinical trials.

The new multi-sponsor site, clinicalstudydatarequest.com, has been launched by the enterprise software provider ideaPoint, which provides the technology behind the site’s secure request and evaluation process. 

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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.