Regulatory Focus™ > News Articles > Researchers Launch Campaign Calling for Clinical Data Transparency

Researchers Launch Campaign Calling for Clinical Data Transparency

Posted 30 October 2012 | By

The British Medical Journal (BMJ) has launched a new regulatory-focused initiative it hopes will spur EU regulators to mandate the public release of data generated during the course of clinical investigations into healthcare products.

In a series of articles released in its 29 October 2012 issue, the BMJ said it was joining with a host of other data transparency campaigners, including author Ben Goldacre and the editors of several prestigious medical journals in the hopes of getting more data published.

The "Open Data Campaign," as it is being called, is the result of concerns, raised in 2009, that eight out of 10 studies on the influenza treatment Tamiflu were never published, raising questions regarding what those studies showed. In the ensuing months, Roche made a promise to the BMJ that it would publish all study data related to the treatment. "Roche intends to make these data available to the scientific community," it said.

Three years later, wrote BMJ's Fiona Godlee in a letter to Roche, researchers still do not have access to that data. "Reviewers now know that there are at least 123 trials of Tamiflu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remain unpublished," she wrote. "On behalf of the Cochrane collaborators and public health decision makers around the world, I am asking Roche to honor its publicly stated promise to make available the full clinical study reports."

Roche has not yet made any statement available to BMJ or the media on the topic.

But while campaigners said their initial efforts were focused on pressuring Roche to honor its 2009 agreement, they said their ultimate goal was a broader degree of transparency.

"[Industry has] persistently and systematically over decades it has withheld and misreported data from clinical trials," opined Godlee in a separate BMJ article. "As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people's lives and wasting public money."

"Such willful distortion is scientific misconduct," Godlee charged, and called on legislators and regulators to make full transparency a basic requirement. The European Commission has released new measures to overhaul the clinical trials directive and institute greater levels of transparency, but Godlee said the proposals do not go far enough.

"All information affecting patient care, from all clinical trials, new and old, on all drugs in current use, must be made available to health professionals," she concluded. "Until that happens, patients will continue to suffer unnecessarily."

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