Few trial sponsors meet data reporting deadlines
Source: NIH / Wikimedia Commons
Drug companies and others have an ethical and, increasingly, legal obligation to promptly report results of clinical trials to registers set up exclusively for this purpose.
In a study published in The New England Journal of Medicine (online, 12 March 2015) researchers looked at 13,327 clinical trials that were expected to report their findings to the US clinicaltrials.gov register. The analysis found that only 13.4% met the 12-month deadline: 17% of industry-sponsored trials, 5.7% of trials funded by the government or academia and 8.1% of trials sponsored by the National Institutes of Health (NIH).
Within five years of trial launch, 38.3% of trials had disclosed their results to the US register (41.5% of industry-sponsored trials; 27.7% academia/government and 38.9% NIH).
Despite a law change in the United States to ensure public disclosure of clinical trial data, trial sponsors have a long way to go to meet public and political expectations.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068121