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GSK wants collaborative approach to data sharing

Calls for pharma companies to share 'independent data custodian'
GSK GlaxoSmithKline house

Pharma companies need to collaborate to work out an effective way to share trial data, according to a senior figure at GlaxoSmithKline (GSK).

Tatjana Poplazarova, director of scientific and public disclosure at GSK Biologicals, said that it was “common sense” for different pharma companies to develop a shared method of data disclosure as more firms commit to improving the transparency of their clinical trials.

Poplazarova was speaking at the European Meeting of the International Society for Medical Publications Professionals (ISMPP), which was held last week in London.

She said that GSK – which has taken the lead among pharma companies with its commitment to provide access to trial data – had “got the ball rolling” on its plans, but collaboration was needed further down the line.

GSK's plan involves the use of an 'independent data custodian', according to Poplazarova. This custodian would receive data from GSK and then, if requested, distribute this data to researchers once they had been assessed by an independent third party.

Researchers would then be requested to publish the work of any research carried out using this data.

According to Poplazarova, this process is the best method to ensure the data sharing process was “objective and standardised”.

Ideally, this independent data custodian would be shared by any pharma company willing to open up access to its trial data, not only to reduce conflict of interest, but to reduce costs and make the process of obtaining data as simple as possible for valid researchers.

Such a collaborative approach should also expand beyond pharma companies, Poplazarova told PMLiVE, and academic researchers or research organisations who want to share data should also be able to do so using the same data custodian.

Last year, GSK became the first pharma company to commit to sharing trial data by signing up to the AllTrials campaign – a pressure group formed to encourage greater transparency of drug data.

Since then, other companies, such as Leo Pharma, Boehringer Ingelheim and Sanofi, have all voiced their own commitments to improve the data sharing process

The European Federation of Pharmaceutical Industry Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have also launched a policy for their members, whereby researchers are able to submit proposals to receive access to patient level data, protocols, and clinical study reports (CSRs) for new medicines approved in the US and EU after January 1, 2014.

Article by
Thomas Meek

23rd January 2014

From: Research



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