Studies: Researchers Fail To Report Clinical Trial Data to Federal Website

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Many researchers are not following through on a federal requirement to post clinical trial results to the NIH website ClinicalTrials.gov, according to a series of six studies published in the British Medical Journal, Reuters reports.

In 2007, FDA issued rules requiring researchers to publish a results summary on ClinicalTrials.gov for all eligible clinical trials within a year of the study's completion.

BMJ Studies

In one of the new BMJ studies, researchers looked at data from 2009 and found that only 22% of the eligible trials on ClinicalTrials.gov had been posted within 12 months of the study's completion (Kelland, Reuters, 1/4).

Andrew Prayle -- lead author of the study and a researcher at the University of Nottingham -- said he hoped the study findings would encourage more researchers to post clinical trial data to the NIH website.

Another study found that fewer than 50% of all NIH-funded trials were published in a peer-reviewed journal within 30 months of completion and about 33% of NIH-funded trials remained unpublished after 51 months (Fauber, Milwaukee Journal Sentinel, 1/3).

In a third study, researchers found that at when meta-analyses of drug trials account for previously unpublished data, they often find different results (Reuters, 1/4).

Links to the three additional studies are provided below:

Accompanying Editorial

In an editorial accompanying the studies -- Richard Lehman, a consulting psychiatrist at the University of Oxford and Elizabeth Loder, a BMJ contributing editor -- called for stronger enforcement of the requirements for posting clinical trial data online. They wrote, "Concealment of data should be regarded as the serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organizations" (Fauber, MedPage Today, 1/3).


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