BMJ will require authors to disclose clinical trial data

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Starting next year, the BMJ will not publish academic papers on drugs or devices unless the relevant anonymized patient-level data are made available for third-party study.
 
The medical journal, which announced the new policy yesterday, will require this commitment for all clinical trials of drugs and devices—whether industry funded or not—beginning in January 2013.
 
In an editorial about the requirement, BMJ's Fiona Godlee, editor in chief, said that the fact that such data are kept private has made it harder to assess drug safety and efficacy.
 
The journal's show of publishing power is the latest move to try and get drugmakers to take the wraps off data.
 
Earlier this year, Cochrane Collaboration researchers, attempting to write a systematic analysis of the drug Tamiflu, accused Roche of reporting biases in the trial program for the drug.
 
When patient-level clinical research data—the detailed data that sit behind the results of clinical trials—are made available for independent scrutiny, academics and companies say, patients and providers can make better treatment decisions about drugs.
 
While this data is often withheld by industry, for ostensibly competitive reasons, some have pledged to open up. Medtronic, faced with controversy over a product, pledged to release all relevant clinical research data into the public domain in a partnership with Yale University.
 
And GlaxoSmithKline, which has also faced controversy on its drugs such as Avandia, this month said that it would make such data available from its trials.
 
In a statement today about the BMJ commitment on clinical trial transparency, GSK's Patrick Vallance, president, pharmaceuticals R&D, noted, “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.”
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