Study: Clinical trial data aren’t measuring up

January 12th, 2015

A recent study of the ClinicalTrials.gov database shows that researchers and trials are coming up short.

The ClinicalTrials.gov database was created in 1997, and researchers were required to register with the database beginning in 2004. But in the ensuing years, the data has shown to fall short. Researchers at Duke University saw data from 96,346 and found that while there were more studies registered since 2004, many studies are too small to be clinically helpful, while others are missing data.

"Despite important progress, ClinicalTrials.gov is coming up short, in part because not enough information is being required and collected, and even when investigators are asked for information, it is not necessarily provided,” Robert Califf, MD, and colleagues wrote in the study.

Ninety-six percent of the studies had anticipated enrollment of no more than 1,000 participants, and 62% had 100 or fewer. Oncology trials were seen to be less likely to use randomization and blinding than oncology or mental health trials. Forty-seven percent were not funded by industry or the NIH. Some studies had up to 71 primary outcomes.

"While there are many excellent small clinical trials, these studies will not be able to inform patients, doctors and consumers about the choices they must make to prevent and treat disease," Carliff and colleagues stated.

So where does this leave ClinicalTrials.gov? Some analysis of the study states that too much is being expected of a website created to give the public at large access to info on clinical studies. In other words, researchers should not count on it as a complete repository of study data.

In any case, it looks like it’s back to the drawing board in forming reporting requirements and enforcement.