Open Access News

News from the open access movement


Friday, November 28, 2008

Impact of OA on clinical trial results

Maxine Clarke, Positive skew of clinical-trial publication, Peer-to-Peer, November 27, 2008.

A news story in Nature Medicine discusses an investigation into the publication status of the clinical-trials literature, which concludes that positive results of clinical trials for drugs or devices have a higher chance of getting published than negative trials. ...

This 'positive publication bias' is a serious problem, because it can make a drug or device appear in the literature to be more effective than it is. ...

According to the Nature Medicine article, a paper in Science indicates that "the FDA Amendments Act of 2007 has improved transparency, because the law mandates that sponsors or primary investigators of clinical trials for approved drugs post a summary of their results in a national open-access database. The lead author of the report, Deborah Zarin, oversees the ClinicalTrials.gov registry at the National Library of Medicine of the US National Institutes of Health ...