Bulk of Medical Trial Results Go Unreported: STUDY

By Staff Reporter - 12 Mar '15 03:01AM

Many researchers are not reporting the results of their studies within a year as a 2007 law requires them to do so, according to a study in Thursday's New England Journal of Medicine.

Researchers found that just one out of every trials met federal requirements to report their results on ClinicalTrials.gov. within a year of the completion of the study. The site garners almost 60,000 unique vistors per month.

A study from Duke University finds that five years after the reporting law took effect, only 13 percent of scientists running clinical trials had reported their results.

Out of more than 13,000 completed or terminated trials in the registry from 2008 to 2013 subject to the reporting requirement, result summaries for only 13.4 percent appeared there, according to Monique L. Anderson, MD, of Duke University, and colleagues.

"We were really surprised to find that reporting certainly isn't timely, and hardly anybody is doing it," said study author Dr. Monique Anderson, a cardiologist at Duke University School of Medicine, in Durham, N.C.

"My savvy cardiology patients want to know about the results of clinical trials, and how these results will affect them," she said. "If we're making a promise to make those results available, we should uphold that promise."

The delays can deprive patients off valuable information that is needed to treat serious as well as potentially life-threatening ailments according to Anderson.

"There's been a lot of prior concern that industry often withheld evidence that came to light later about their medical products, and that medical journals were selectively reporting the positive results from trials," Anderson said.

In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about clinical trials. Seven years later, the mandate expanded to require sponsors of most trials to begin registering and reporting basic summary results on the registry so the American public could have access to the trial results.