Sponsors aren't reporting clinical trial data like they are supposed to, according to an analysis performed by Duke University researchers.
Part of the Food and Drug Administration Amendments Act requires sponsors to register their non-phase I clinical trials of drugs, medical devices, or biologics, and report basic summary results at ClinicalTrials.gov within a year of the completion of data collection.
As they report in the New England Journal of Medicine this week, Duke's Monique Anderson and her colleagues identified more than 13,300 clinical trials that ended between January 2008 and August 2012 that they deemed to be subject to that requirement.
About 13 percent of these trials, the researchers say, reported their results within 12 months and about 38 percent reported them within five years. Within that first year, 17 percent of trials funded by industry, 8 percent of trials funded by the National Institutes of Health, and almost 6 percent of trials funded by other government or academic institution reported their results. The median time to reporting was 17 months, the researchers add.
"We were really surprised to find that very few people are following the law," Anderson tells NPR.
There are, NPR adds, various reasons why investigators may be slow or hesitant to report results. They may simply be too busy, or they might not want to admit their trial didn't work.
Anderson and her colleagues note that penalties of $10,000 a day and a loss of NIH funding have been established for failing to submit results, but that has not been enforced as the rule has not yet been approved.