Tag Archives: ClinicalTrials.gov

FDA promises crackdown on researchers who fail to properly register and report studies

Photo: Ferrous Büller via Flickr

For two decades, researchers have been required to register clinical trials that use any U.S. federal funding at ClinicalTrials.gov before they begin the study. The requirement grew out of a 1997 law aiming to increase transparency with studies that tested drugs, procedures or other treatments on people.

Researchers had to include the planned protocol, including endpoints, when registering their trial. If the endpoints changed during the trial, their registration had to be updated, including the reasons for the change. As of 2007, the law required all trial registrations to be completed within a year after the trial began, regardless of the trial results. Continue reading

Greater transparency is resulting in fewer ‘positive’ findings in clinical trials

FreeImages.com/Cristian Bender

FreeImages.com/Cristian Bender

If it seems the newest studies are always reporting some new link – an association between two things or an increase or decrease in this, that or the other – it’s not your imagination.

Positive findings, those which find … “something,” tend to end up in journals more often. But a recent study in PLOS ONE suggests that this trend has decreased, thanks to a change in trial reporting standards around the year 2000. Continue reading