GlaxoSmithKline grants researchers access to clinical trial dataBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6909 (Published 12 October 2012) Cite this as: BMJ 2012;345:e6909
GlaxoSmithKline has taken steps to open up more clinical data behind its drug trials, just months after the company was fined a record amount for ethical breaches.
From January all anonymised patient level data that sit hidden behind the results of clinical trials of its approved and failed drugs will be available without charge through a secure website once access has been approved.
Andrew Witty, GSK’s chief executive, said that the move sprang from a desire to dismiss the perception that drug companies are always “hiding something.”
“People have to really believe they are looking at the whole picture,” he said at the launch of the initiative on 11 October at the Wellcome Trust in London. “We will make available the raw data at patient level from all our trials—you can’t get anything more granular than that.”
The announcement comes after GSK was fined a record $3bn (£1.9bn; €2.3bn) in July for several offences, including hiding negative findings from trials of the drug paroxetine and for failing to report safety data on the antidiabetes drug rosiglitazone.1
GSK is the first major drug company to open up data in this way, a move that Witty hoped would lead to further drug discovery. Crucially, it gives scientists the freedom to use the clinical trial data without working with GSK, either to examine findings more closely or to combine data with different studies in further research. It opens up the possibility of researchers mining data relating to the trials of controversial and discredited drugs, such as rosiglitazone.
To access data, researchers have to get permission from an independent panel of experts. The panel of gatekeepers, which would not “just be made up of friends of GSK,” said Witty, would consider requests on their scientific merits.
“We don’t want people with no understanding of data to go through and make random conclusions. The panel will ask, ‘Do you have a protocol, are you asking a legitimate research question, and will you publish the results?’” said Witty.
“Just as patients have given us this data, we shouldn’t then say this data is available to anyone.”
Once approved, trial data from 2007 and beyond would be automatically available, although data relating to trials staged before this date would be “less easy” to access. This was because pre-2007 trial data weren’t collected in a standard electronic format, but GSK said that its commitment to opening up the data remained the same.
Mark Walport, director of the Wellcome Trust, said that GSK’s move was bold and innovative. “Real breakthroughs do not come out of nowhere but are borne of scientists sharing knowledge and learning from each other.”
At the same time GSK’s tuberculosis “compound library” is to be made freely available. This will make public the company’s proprietary compounds that have shown signs of activity against tuberculosis. In 2009 GSK placed all its malaria compounds in the public domain.
Cite this as: BMJ 2012;345:e6909
See Elizabeth Loder’s BMJ Group blog “Liberating clinical trial data” at http://blogs.bmj.com/bmj/2012/10/09/elizabeth-loder-liberating-clinical-trial-data.