The Food and Drug Administration Amendments Act requires researchers to submit clinical trial results to ClinicalTrials.gov within a year of completion. However, a new study indicates that only 13.4% of trials comply.

Thousands of U.S. researchers aren't following the law that requires prompt reporting of clinical trial results to ClinicalTrials.gov, a new study shows. Only 13.4% of the trials that are covered by the law met the reporting deadline.

Passed in 2007, the Food and Drug Administration Amendments Act specifies that researchers conducting a non–phase I trial of a drug, biologic, or medical device submit their findings to ClinicalTrials.gov within 1 year of the trial's completion. Previous studies have suggested that only a fraction of trials adhere to that stipulation, but their conclusions relied on small samples.

Monique Anderson, MD, of Duke University Medical Center in Durham, NC, and colleagues wanted to gauge overall compliance with the law. Determining which of the more than 180,000 trials listed on ClinicalTrials.gov are covered by the 1-year requirement entailed more than just checking their completion dates, however. A company testing a new drug to treat melanoma, for instance, is exempt from the requirement if it plans to seek FDA approval for the drug. It can wait until after the drug's approval to share trial findings.

Anderson and colleagues worked with staff of the National Library of Medicine (NLM), which runs ClinicalTrials.gov, to create an algorithm that identifies trials likely to be subject to the reporting requirement. They determined that about 13,300 trials that concluded between January 1, 2008, and August 31, 2012, fell into that category.

“We show that very few trial sponsors are reporting on time,” Anderson says. As she and her colleagues revealed last month in The New England Journal of Medicine, sponsors submitted results for only 13.4% of trials within a year. Industry-funded trials had the highest reporting rate at 17%, followed by NIH-funded trials at 8.1%, and trials underwritten by universities or other sources at 5.9%.

Lack of knowledge about the law and who is subject to it could be one reason for the poor compliance, according to Anderson. The time required to prepare and submit trial results—which one report suggested could be up to 60 hours—might also be a factor. To increase reporting, the NLM and the FDA need to step up their education and notification efforts, Anderson says. Journal editors could also help by requiring submission of results to ClinicalTrials.gov as a condition of publication, she adds.

ClinicalTrials.gov has taken several steps to encourage compliance, says Rebecca Williams, PharmD, the site's assistant director. For example, the staff notifies sponsors whose trials are probably subject to the reporting requirement, and they've organized workshops to educate researchers about their obligations. “The main thing that needs to be done … is the sponsors of studies taking responsibility for the time limits and quality of submissions,” she says. “When in doubt, report.”

So far, no one has been sanctioned for missing the submission deadline because the Department of Health and Human Services hasn't issued final regulations that spell out how the law will be enforced. However, once that happens, the FDA could fine sponsors who don't follow the law up to $10,000 per day. Sponsors could also lose NIH funding.