Anyone looking for the outcomes of thousands of closed or completed clinical trials isn't likely to find them, despite government mandates requiring the data be made available.
More than 80% of trials that should have posted results had not done so within one year of completion, and government funded research was the least likely to share findings, according research looking at clinical trial data between 2008 and 2012.
The inability to access trial data has been a bane of researchers, especially those trying to compare the effectiveness and optimal use of newer, more expensive therapies.
In an effort to address such concerns earlier this year, the Institute of Medicine proposed vast changes to how data is shared.
But critics remain dubious that the IOM's efforts will translate into actual practice. Movement toward transparency has remained markedly slow. In the meantime, the existing reporting mandates remain essentially unenforced, and reporting levels are low.
“It's just ethically pathetic,” said Art Caplan, a bioethicist and founding director at the in NYU Langone Medical Center's Department of Population Health. Researchers studying human subjects have a duty to share data as a way to let the scientific community know what's going on, he said. “If you don't do that, you're breaching your covenant.”
In the new study, researchers from the Duke Clinical Research Institute identified 13,327 trials that were “highly likely” to be subject to FDA mandates that require the researchers to report the results.