US Judge rules that a decade of unpublished trial results must be made public
A federal judge in New York’s Southern District has ruled that 10 years of unpublished clinical trial data must now be made public – a judgement which could have vast implications for possibly over 1,000 unpublished studies between 2007 and 2017.
The case was originally brought two years ago by plaintiffs Peter Lurie and Charles Seife, an associate FDA Commissioner and a New York University Professor of Journalism who has been published in Science, among other publications. It accused government agencies like the FDA, Department of Health and Human Services and the National Institutes of Health of failing to enforce the requirements of the Final Rule of the FDA Amendments Act.
As stipulated by the rule, the full results of any clinical trial must be uploaded to the government repository ClinicalTrials.Gov within 12 months of completion to be accessible to the public, regardless of whether the results were positive or negative.
“The FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it’s nearly impossible to understand whether the agency is doing its job properly,” Seife said in a statement.
The ruling follows a recent report which revealed that only 41% of all US-based clinical trials in the US had reported their findings “promptly”, and 36% did not report their findings at all, with non-industry institutions like hospitals and universities being the worst offenders.
Despite the provision under the law to issue a fine of up to $10,000 a day for non-compliance, a report in Science noted that the FDA has never imposed this on any offending body.
“This decision brings us one step closer to what federal law requires – providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” commented Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic who represented Lurie and Seife, adding that the judgement “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavourable trial results secret.”
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