Another Bill Calls For Clinical Trial Data Transparency
A US Congressman has introduced legislation requiring study results of all clinical trials – positive and negative – to be registered at ClinicalTrials.gov, with failure to comply resulting in loss of eligibility for grants.
“Knowing if a clinical trial failed is just as important as knowing if a trial is successful so millions of dollars are not wasted by other researchers attempting the same research efforts,” says Republican Tom Reed in a statement in which emphasizes the goal is to improve cancer research. “It’s vitally important all trial results are shared so that we might better understand the results to provide better care and advance our shared goal of finding a cure.”
Reed stresses that while similar legislation is already in place, it's not enforceable, and the key challenge now is coming up with a system of unavoidable sanctions that would act as a deterrent against non-reporting of trials. According to a study published in the BMJ, only 22% of trials are reported. Another paper, which looked at the rate of reporting of trials funded by the National Institutes of Health between 2005 and 2008, found that only 46% made it into a peer reviewed medical journal within thirty months of completion, while three years later, one in three remained unpublished. Meanwhile, researchers from the University of Minnesora School of Public Health recently reported that only 29% of all trials registered at ClinicalTrials.gov were ever published, and when publication took place, it took on average two years after study completion.
The new bill comes amidst a growing debate over clinical trial transparency started in the UK earlier this year by Ben Goldacre, the author of Bad Pharma, the British Medical Journal, Sense About Science, Sir Iain Chalmers, and Oxford Centre for Evidence-Based Medicine. At the end of April the campaign launched in the US, where it is supported by Dartmouth Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice.
So far more than 48,000 people and 250 organizations, including more than 100 patient advocacy groups, signed the petition for all trials to be registered and their results reported. In February 2013, GSK became the first pharmaceutical company to join the campaign. The move came after GSK paid a US$3 billion fine to the US government to settle civil and criminal charges, some of which involved a failure to disclose data about its diabetes pill, which was linked to higher rate of heart attacks and strokes.
“Doctors and patients need the results of clinical trials to make informed decisions about which treatment is best. When trial results are withheld, we cannot practice medicine safely and effectively,” said Goldacre.
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