Few trial sponsors meet data reporting deadlines

Drug companies have an ethical and legal obligation to promptly report results of clinical trials to registers but few meet the reporting deadlines. Pictured, National Institute of Health (NIH) Clinical Research Center in Bethesda, Maryland

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
[1]
(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.

References

[1] Anderson ML, Chiswell K, Peterson ED et al. Compliance with results reporting at ClinicalTrials.gov. The New England Journal of Medicine 2015; 372:1031–1039. doi: 10.1056/NEJMsa1409364.

Last updated
Citation
The Pharmaceutical Journal, PJ, 21/28 March 2015, Vol 294, No 7854/5;294(7854/5):DOI:10.1211/PJ.2015.20068121