GSK backs campaign for disclosure of trial dataBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f819 (Published 07 February 2013) Cite this as: BMJ 2013;346:f819
The UK based pharmaceutical giant GlaxoSmithKline has become the first drug company to sign up to a campaign for all clinical trials to be registered and their full results disclosed.
The AllTrials initiative (alltrials.net) was set up in January by the charity Sense About Science, the BMJ, and other supporters of transparency in research.1 It is calling for registration of all clinical trials and for full study results and full clinical study reports (CSRs) to be made publicly available.
CSRs are formal study reports that provide more details on the design, methods, and results of clinical trials than published papers and form the basis of submissions to drug regulators, such as the European Medicines Agency, when drug companies seek to have their drugs approved.
GSK said that it would publish CSRs, with the patient data stripped out, for all of its drugs once they had been approved or discontinued from development and the results had been published. It would also publish CSRs for clinical outcomes trials for all approved drugs from 2000, the company said, although this could take many years.
However, it is anonymised patient level data that the BMJ has been calling for in its open data campaign. This would allow researchers at the Cochrane Collaboration to scrutinise the data on Roche’s drug oseltamivir (Tamiflu), something the researchers have been trying to do since 2009.2
To get to this depth of data in GSK trials, researchers have to submit a request to a panel of experts assembled by the company, in a scheme announced by the company in October.3 This panel may not necessarily approve the request. If approval is given, researchers would be able to look at the data in a “secure environment,” a spokeswoman for the company told the BMJ.
Ben Goldacre, author of the book Bad Pharma and a backer of the AllTrials campaign, welcomed GSK’s announcement. In a blog he said, “I couldn’t be any happier. This is huge, and internationally huge. GSK have made a commitment to post CSRs online. Because they have discussed these technical details—while I will always wait for the proof in the pudding—I do not believe this is mere lip service.”4
Ana Nicholls, a healthcare analyst at the Economist Intelligence Unit, welcomed GSK’s stand on data disclosure but said that there was “still distrust about whether it is keeping information back.” That distrust has deepened, she said, since 2011, when the company agreed to pay $3bn (£2bn; €2.2bn) in fines and civil settlements in the United States after pleading guilty to promoting two antidepressants for unapproved uses and failing to report safety data on rosiglitazone to the Food and Drug Administration.5
Tom Jefferson, an independent epidemiologist with the Cochrane Collaboration, said that it was not clear whether GSK was going to publish full CSRs. He told the BMJ, “Our experience with Tamiflu has shown that often nothing short of full disclosure of the full trial programme enables a fair assessment of a drug’s performance. The time for scrutinising committees is over.”
Cite this as: BMJ 2013;346:f819