News

GSK backs BMJ’s new policy to publish only studies with full access to data

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7404 (Published 01 November 2012) Cite this as: BMJ 2012;345:e7404
  1. Zosia Kmietowicz
  1. 1London

The announcement this week that the BMJ will publish clinical trials only if the researchers have agreed to provide detailed patient level data when requested has been applauded by the drug firm GlaxoSmithKline.

Fiona Godlee, editor in chief of the BMJ, said in an editorial that the journal “will require this commitment for all clinical trials of drugs and devices—whether industry funded or not—from January 2013.”1

In response, Patrick Vallance, president of pharmaceuticals research and development at GSK, said: “GSK fully supports the commitment made today by BMJ to drive greater transparency of clinical trial data. Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines. Ultimately this should improve patient care.

“At GSK we already post results from all our clinical trials—whether positive or negative—on our website. We also aim to publish these in peer reviewed journals such as BMJ. GSK’s ultimate goal is to see a broad system develop where the clinical research community can access data from trials conducted by different organisations. We want to work with others to make this happen.”

In October GSK announced that from January 2013 it would allow researchers to have access to data related to its clinical trials if the request was approved by an independent panel of experts.2

A recent poll on bmj.com asked: “Who is mainly at fault for denying access to negative clinical trial results?” It found that of the 569 votes, 69% said pharma, 13.5% said regulators, and 9% said legislators.

Godlee said that the details of the new BMJ policy were still being determined but that the journal would publicise instances in which requests were rejected. She hoped that other major journals would follow the BMJ’s example: “We expect that eventually this will become the norm.”

The move to greater transparency is part of a campaign by the BMJ and others to secure access to the results of all clinical trial data whether positive or negative. A recent letter in the Times from Godlee and others called on the government to take action to end the “ongoing secrecy” that surrounds the reporting of clinical trials.3

Earlier in October the minster for care services, Norman Lamb, committed the government to a meeting with campaigners.4

The BMJ has also launched its first “open data” campaign, which aims to put pressure on Roche to fulfil a promise it made in 2009 to release full clinical trial reports on oseltamivir (Tamiflu). Roche, which has made billions of pounds from countries stocking up on the drug, made the commitment after a Cochrane review concluded that the evidence on the drug could not be relied on because eight of the 10 trials that Roche used to prove its effectiveness have never been published.5

Releasing the data would allow independent academics to answer questions about oseltamivir’s effectiveness, but the data remain undisclosed.

Peter Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine, Baltimore, Maryland, and one of the authors of the Cochrane review, welcomed the change in the BMJ’s publishing policy. He told the New York Times, “I think that’s a very powerful and important step.”6

Notes

Cite this as: BMJ 2012;345:e7404

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