Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

sections

Clinical trials

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

Source: NIH / Wikimedia Commons

Only  8.1% of trials sponsored by the National Institutes of Health met the 12-month reporting deadline

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.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068121

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.